clinical research associate que es

¿Qué es ser un CRA?

Un CRA, o Clinical Research Associate, es un profesional que se encarga de supervisar y coordinar los ensayos clínicos en el ámbito de la investigación médica. El CRA se encarga de asegurar que los ensayos se realicen de acuerdo a los protocolos establecidos, garantizando la seguridad de los participantes y la calidad de los datos obtenidos.

El trabajo de un CRA implica la visita periódica a los centros de investigación donde se están llevando a cabo los ensayos clínicos. Durante estas visitas, el CRA se asegura de que se sigan los procedimientos adecuados, revisa los registros y documentación, y se comunica con el equipo investigador para resolver cualquier duda o problema que pueda surgir. También es responsable de mantener una comunicación fluida con los patrocinadores del estudio, informando sobre el progreso y los resultados obtenidos.

Además de las visitas a los centros de investigación, el CRA también desempeña un papel crucial en la selección de los sitios de estudio y la capacitación del personal involucrado en el ensayo clínico. Debe asegurarse de que los investigadores y miembros del equipo estén debidamente capacitados y cumplan con los requisitos éticos y legales necesarios.

La labor de un CRA requiere de un alto nivel de organización, capacidad de análisis y atención al detalle. Es fundamental seguir los lineamientos y protocolos establecidos, así como mantener un registro preciso y detallado de todas las actividades realizadas. Además, el CRA debe tener habilidades interpersonales para trabajar eficientemente tanto con el equipo investigador como con los patrocinadores y otros profesionales de la salud.

En resumen, ser un CRA implica ser un responsable en la supervisión y coordinación de ensayos clínicos, asegurando el cumplimiento de los protocolos establecidos y la calidad de los datos obtenidos. El CRA juega un papel clave en la investigación médica, contribuyendo al avance científico y al desarrollo de nuevos tratamientos y terapias.

¿Qué se necesita para ser un CRA?

Para ser un CRA (Clinical Research Associate), se requiere una combinación de habilidades, conocimientos y experiencia en el área de la investigación clínica.

En primer lugar, es fundamental contar con una formación académica en ciencias de la salud o áreas afines. Esto proporciona una base sólida de conocimientos en anatomía, fisiología, farmacología y metodología de investigación clínica.

Además, es necesario poseer habilidades de comunicación excelentes para interactuar con diversos profesionales de la salud, investigadores y pacientes. Un CRA debe ser capaz de explicar claramente los protocolos de estudio, recabar información precisa y brindar orientación y apoyo a los investigadores.

Otra habilidad clave es una atención meticulosa al detalle . Un CRA debe revisar cuidadosamente los datos recopilados, registros médicos y protocolos de estudio para garantizar su precisión y cumplimiento. Además, debe ser capaz de detectar posibles errores o discrepancias y tomar medidas correctivas de manera oportuna y eficiente.

La organización y la capacidad de gestionar múltiples tareas simultáneamente son esenciales para un CRA. Este profesional debe mantenerse al tanto de varios estudios clínicos a la vez, coordinar visitas a los sitios de investigación, recolectar datos y mantener la documentación actualizada.

También es necesario tener conocimientos sólidos de regulaciones y normativas en la investigación clínica. Un CRA debe estar al tanto de las pautas éticas y legales que rigen los ensayos clínicos, así como de los requisitos específicos de las autoridades sanitarias y los comités de ética.

Finalmente, un CRA debe ser flexible y capaz de adaptarse rápidamente a los cambios en los protocolos de estudio, plazos y requisitos. Esta profesión requiere una mentalidad proactiva y la capacidad de resolver problemas de manera efectiva.

En resumen, para ser un CRA se necesita una formación académica en ciencias de la salud, habilidades de comunicación, atención al detalle, capacidad de gestión, conocimiento de regulaciones y flexibilidad. Estas características permiten a un CRA desempeñar un papel crucial en la investigación clínica y contribuir al avance de la medicina.

¿Qué significa CRA en España?

CRA en España significa Centro Rural Agrupado . Un CRA es una agrupación de pequeñas escuelas situadas en zonas rurales con pocos alumnos. Estos centros están diseñados para dar servicio educativo a localidades pequeñas que de otro modo no podrían contar con una escuela propia.

Un CRA suele estar compuesto por varias escuelas rurales que comparten recursos y personal docente. Esto permite que los alumnos de estas localidades tengan acceso a la educación de calidad en su propio entorno sin tener que desplazarse largas distancias.

En un CRA , los alumnos de diferentes edades comparten el mismo espacio educativo. Esto fomenta el aprendizaje colaborativo y facilita la integración entre los estudiantes de distintos niveles. Además, los profesores pueden adaptar las actividades y el ritmo de aprendizaje según las necesidades de cada alumno.

El concepto de CRA busca garantizar la igualdad de oportunidades educativas para los niños que viven en zonas rurales y así evitar la despoblación de estas áreas. Además, permite mantener viva la cultura y la tradición de los pueblos, ya que los estudiantes pueden aprender y valorar su entorno local.

¿Cuánto cobra un Coordinador de ensayos clínicos?

Un Coordinador de ensayos clínicos es un profesional de la salud encargado de organizar, supervisar y llevar a cabo ensayos clínicos para probar la eficacia y seguridad de nuevos medicamentos o tratamientos. Su labor es esencial dentro del ámbito de la investigación médica, ya que contribuye al avance y desarrollo de nuevos tratamientos y terapias.

El salario de un Coordinador de ensayos clínicos puede variar según diferentes factores, como la experiencia, el nivel de responsabilidad y la ubicación geográfica. En términos generales, un Coordinador de ensayos clínicos puede cobrar entre 30.000 y 60.000 euros al año , aproximadamente. Sin embargo, hay situaciones en las que este salario puede superar los 80.000 euros, especialmente en casos de coordinadores con una amplia trayectoria y experiencia en estudios clínicos de alta complejidad.

Es importante tener en cuenta que los salarios mencionados son solo una referencia y pueden variar según el país y la empresa en la que se trabaje. Además, los coordinadores de ensayos clínicos también pueden recibir beneficios adicionales, como bonificaciones por desempeño, seguros médicos y otros incentivos.

En cuanto a los beneficios de convertirse en Coordinador de ensayos clínicos, este trabajo ofrece la posibilidad de contribuir al avance de la medicina y mejorar la salud de las personas. Además, es una profesión que brinda estabilidad y perspectivas de crecimiento, ya que la demanda de profesionales en este campo es alto y continúa en aumento. También es una profesión que permite mantenerse actualizado en cuanto a los últimos avances científicos y tecnológicos en el campo de la medicina.

En resumen, ser un Coordinador de ensayos clínicos es una profesión gratificante tanto a nivel económico como personal. Los salarios pueden oscilar entre los 30.000 y 60.000 euros al año, aunque pueden superar los 80.000 euros en casos excepcionales. Además, ofrece beneficios adicionales y perspectivas de crecimiento a largo plazo. Si estás interesado en la investigación médica y te apasiona contribuir al avance científico, esta puede ser una carrera prometedora para ti.

¿Qué es un CRA en medicina?

Un CRA en medicina se refiere a un Coordinador de Ensayos Clínicos. Este profesional juega un papel fundamental en la investigación médica y trabaja en estrecha colaboración con los investigadores, médicos y pacientes. Su principal responsabilidad es asegurar que los ensayos clínicos se llevan a cabo de manera ética, segura y eficiente.

El CRA es una figura clave en la fase de desarrollo de nuevos medicamentos. Su trabajo consiste en coordinar y supervisar todos los aspectos de los ensayos clínicos, desde la selección de los pacientes adecuados hasta el seguimiento de los datos recopilados. También se encarga de garantizar que se cumplen todas las regulaciones y normativas establecidas por los organismos competentes.

Para desempeñar su labor, el CRA debe tener una sólida formación en medicina, además de conocimientos en áreas como la farmacología, la bioestadística y las regulaciones sanitarias. También es necesario que posea habilidades interpersonales para poder establecer y mantener una comunicación efectiva con los diferentes actores involucrados en el ensayo clínico.

El CRA realiza visitas periódicas a los centros de investigación para evaluar el progreso de los ensayos clínicos y brindar apoyo técnico y logístico. Además, se encarga de revisar y analizar los datos recopilados, asegurando su calidad y confiabilidad. También tiene la responsabilidad de informar sobre los avances del ensayo clínico a los investigadores, así como de informar a los pacientes sobre el estudio y responder a sus preguntas.

En resumen, el CRA en medicina es un profesional altamente capacitado que juega un papel crucial en la investigación médica. Su labor se enfoca en garantizar que los ensayos clínicos se realicen de manera adecuada y segura, contribuyendo así al avance de la ciencia y al desarrollo de nuevos tratamientos para diferentes enfermedades.

Clinical Research Associate, qué estudiar para acceder a la profesión que más demanda la industria farmacéutica

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Por Daniel Silva Peña. Docente en INESEM Business School. Licenciado en Farmacia, especialista en Psicofarmacología y Drogas de Abuso y PhD con sobresaliente Cum Laude en Psicología.

El Clinical Research Associate, también llamado CRA o monitor de ensayos clínicos , es una profesión cada vez más demandada, ya que representa una pieza fundamental en el complejo engranaje de la realización de los ensayos clínicos, un campo muy amplio en el que se insertan múltiples perfiles laborales donde el CRA es, sin duda, un elemento imprescindible. Además este puesto es muy demandado y valorado en muchos países, por lo que si estás pensando en viajar al extranjero para adquirir experiencia, las posibilidades de encontrar trabajo se multiplican. No obstante, es importante resaltar que en nuestro país los ensayos clínicos presentan una actividad más que destacable.

De hecho, con la situación sanitaria actual, España ha dado un paso al frente en lo que a investigación se refiere, siendo el cuarto país del mundo que más estudios está conduciendo sobre tratamientos contra el coronavirus. Pero esto no es algo nuevo o meramente circunstancial, ya que antes de la pandemia España ya era el país con más participación en ensayos clínicos de toda Europa. En cualquier caso, y teniendo en cuenta la elevada demanda de este profesional, la empleabilidad en el sector es altísima.

¿Qué hace un CRA? Lo primero que debe tener claro el CRA, es que su labor se orienta a mejorar la salud de las personas mediante la investigación. El Clinical Research Associate es un profesional encargado de asegurar que un ensayo clínico propuesto por un laboratorio se realice de acuerdo con el protocolo diseñado, respetando todos los aspectos relativos a plazos, seguridad, inclusión de pacientes, etc. Por ello, debe de ser una persona con conocimientos en ciencias de la salud y con capacidad de aprendizaje, ya que deberá de adaptarse a los diferentes estudios que le toque monitorizar, con todo lo que ello conlleva: diferentes metodologías y tratamientos, diferentes equipos investigadores…

¿Qué estudiar para ser Clinical Research? Para poder realizar correctamente este trabajo, necesitas principalmente los dos siguientes aspectos: una formación científica y conocimiento específico del funcionamiento de un ensayo clínico. Por ello, para ser CRA es necesario estar en posesión de un título oficial de cualquier carrera enmarcada dentro de las Ciencias de la Salud (biología, bioquímica, farmacia, enfermería…) y también será necesario poseer un máster en monitorización de ensayos clínicos que te habilite para esta profesión. Además, existen varias formaciones complementarias que serán muy valoradas a la hora de acceder a un puesto de trabajo: cursos relacionados con farmacología, industria farmacéutica… Pero dentro de la formación complementaria, será muy recomendable el contar con un buen nivel de inglés, ya que en ocasiones cierta información relativa a los ensayos clínicos está redactada en este idioma, y además te otorgará la posibilidad de estar en contacto con profesionales del sector de diferentes países.

¿Qué vas a hacer? Habitualmente, el CRA alternará el trabajo de oficina con las visitas a los centros, por lo que, viajar se convierte en un aspecto central de la vida del Clinical Research Associate. De hecho, dado que la maleta se convertirá en tu compañera de trabajo, es importante que te guste viajar y tengas disponibilidad para ello. En estos viajes, el monitor visitará a los distintos centros en los que se está llevando a cabo el ensayo clínico para supervisar que el protocolo de ensayo se esté siguiendo adecuadamente, por lo que deberá de entrevistarse con el equipo investigador, con los KOL, los MSL… por ello, una importante cualidad del monitor de ensayos clínicos es el poseer buenas habilidades sociales y comunicativas, con el fin de establecer redes de confianza que favorezcan el buen desarrollo del ensayo y la implicación y el compromiso de todos los profesionales involucrados en el estudio.

En resumen, si estás interesada o interesado en los ensayos clínicos, como monitor encontrarás una alta empleabilidad dentro de un sector indispensable en el mundo de la ciencia y la salud. Y para trabajar en este campo, el camino a seguir es realizar una carrera de Ciencias de la Salud, obtener el máster en Monitorización de Ensayos Clínicos…

INESEM Business School, Escuela de Negocios Online, trabaja para fomentar y contribuir al desarrollo profesional y personal de sus alumnos. Promovemos una enseñanza multidisciplinar e integrada, mediante la aplicación de metodologías innovadoras de aprendizaje para una aplicación práctica orientada al mundo laboral. Desde INESEM Business School, queremos ser tu Escuela de Negocios Online, en la que desarrollarás y mejorarás tu carrera profesional. Porque sabemos que la clave del éxito en el mercado laboral es la “Formación Práctica” que permita superar los retos que deben de afrontar los profesionales del futuro. Como Escuela de Negocios Online, formamos profesionales capacitados para los trabajos más demandados en el mercado laboral; profesionales innovadores, emprendedores, analíticos, con habilidades directivas, capaces de añadir valor a las empresas en las que estén trabajando y a la sociedad. Y todo esto podemos llevarlo a cabo gracias a nuestros objetivos y valores como Escuela de Negocios online. Cubrimos la necesidad de formación especializada, de calidad y sin barreras físicas, permitiendo compatibilizar el desarrollo profesional con la vida personal.

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How To Become A Clinical Research Associate - A New Scientist Careers Guide

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What does a clinical research associate do?

Clinical research associates (CRAs) are responsible for running clinical research, which consists of trials designed to test new or current drugs/immunisations and analyse their effectiveness, risks, benefits and safety of use. 

CRAs play an important role in the healthcare industry and public health development by helping to design and test new medications, vaccinations and other therapeutic agents.

CRAs can be involved at any stage of a drug development trial, including planning, coordinating and supervising. It is their responsibility to ensure a drug has been appropriately examined and all its risks have been evaluated before it is released to be used publicly.

CRAs most commonly work for pharmaceutical companies or contract research organisations. They might also have to spend some time working in a hospital setting to collect data about the drugs they are analysing. They might also work for universities or public/global health organisations. 

As a CRA, you may have a range of responsibilities depending on your employer, project and level of experience. Typically, CRAs will need to complete tasks such as:

• Designing and writing trial protocols and standard operating procedures
• Presenting protocols and procedures to steering committees
• Designing data collection forms
• Requesting ethics approvals and working with ethics committees
• Liaising with staff conducting the trials, such as doctors or consultants
• Training local staff based on trial-specific standards
• Monitoring operations during clinical trial data collection
• Collecting completed data collection forms
• Performing data management and analysis, and discussing the results
• Closing trials and finalising reports with the help of a statistician

CRAs will work in a team of other research professionals, including contract organisation or sponsor staff, principal investigators and clinical research coordinators.

How to become a clinical research associate

To become a CRA, you need to obtain a degree in medical sciences, life sciences or nursing. This can be in subjects such as biomedical science , anatomy, physiology, immunology , pharmacology or broader degree subjects like chemistry and biology .

Alternatively, you can access a career as a CRA by acquiring a higher national diploma (HND). This is a qualification equivalent to the second year of a bachelor’s degree. HNDs can be beneficial to those who want to enter more practical fields, clinical research included.

Occasionally, you can enter a CRA role from an administrative background. For instance, if you begin working as a clinical trials administrator/assistant and decide you would prefer the role of a CRA, you can complete additional qualifications to do this. However, this will take some time and can be difficult.

Most employees view undergraduate qualifications as sufficient, but in some cases a postgraduate degree may be beneficial. Master’s degrees and PhDs can gain you an advantage when applying for competitive positions, and help you gain more experience in research .

Work experience is key to securing a clinical research job. You can get this at any point in your training, and some universities may help with this. The types of work experience most useful for a CRA role include:

• Academic research
• Pharmaceutical research (e.g. via a pharmaceutical industry placement during your degree)
• Laboratory work
• Nursing or care work
• Work in a pharmacy or medical sales
• Other, similar activities

How long does it take to become a clinical research associate?

Becoming a CRA will usually take around three to four years, depending on the access pathway you choose.

If you opt to complete an undergraduate degree, this can take three to four years. You can then apply to job positions as a CRA straight away. However, if you don’t have sufficient work experience, you may need to start at a lower-level position such as a more administrative job. From here, you can gain more experience and reapply for a higher-level position.

If you choose to obtain a HND qualification, this will take two years. Provided you have sufficient experience, you can then apply for a graduate post as a CRA, but again you may need to gain some extra experience/qualifications in some cases.

If you opt to do a postgraduate degree first, this may take an additional one to three years depending on whether it is a master’s degree or a PhD. Many CRA job positions also allow for completion of postgraduate qualifications alongside the job.

A day in the life of a clinical research associate

Most CRAs work about 40 hours a week, during weekdays. There may be an out-of-hours commitment, for instance if working in a hospital setting monitoring a new drug, but this is dependent on your employer and role.

CRAs can work on multiple trials at a time, in multiple different sites. This will depend on the complexity of each trial and what stage each of the trials is in. Therefore, the role may entail some travelling at times, while other times most of your work will be concentrated on one site.

As a CRA, you will carry out a wide variety of tasks. Some days may be spent writing reports. On other days, you will work on site with healthcare staff , or you might go into your office and attend meetings.

No matter your experience level or how senior your role is, as a CRA, you will need to work in a team with other research and healthcare professionals. You will be communicating with research nurses, doctors, health consultants, investigators and managerial and administrative staff from the company requesting the trial.

The role requires good communication skills, as well as good time management and organisation skills, because carrying out a few different studies at once may mean some tasks clash with one another and you need to prioritise the most important ones.

Clinical research associate: Career options

As with most clinical roles, CRAs undergo lots of continuing professional development (CPD) within their role. There are many training courses available to CRAs to build on their existing skills and develop new competencies.

Most training courses are organised by external bodies, and many are paid for by the employer. One of the organisations that runs training courses is the Institute of Clinical Research (ICR). It provides training in areas such as effective project management for clinical trials and advanced clinical trial monitoring, among several others.

The ICR also offers certificates and a diploma that you can complete to evidence your skills in clinical research. Becoming an ICR member and obtaining courses and qualifications from it can also be beneficial to career development, as you will meet other prominent professionals in your field through interacting with this organisation.

You can also opt to complete a postgraduate qualification, such as a PhD or master’s degree in several different areas, including clinical research and clinical pharmacology .

As mentioned, you may need to climb up the professional ladder to become a CRA, and many people start off as clinical trial administrators or junior CRAs. Within these roles, you might complete tasks such as handling documentation and correspondence or helping to set up trial sites. 

From here, you can move on to becoming a senior CRA as you gain experience. At this point, you will have more advanced responsibilities, such as project management of whole trials and designing case report forms.

If you develop sufficient experience and gain contacts in the field, there is a possibility of self-employment if you want to become a freelance CRA. 

Salary: How much does a clinical research associate earn in the UK and US?

In the UK, starting salaries for CRAs range between £26,000 and £34,000 per year. As a more senior CRA, you might earn between £35,000 and £50,000, and in the most senior positions involving managerial tasks, you might earn upwards of £55,000.

Salaries will vary between regions and employers, as well as depending on your level of experience and responsibilities. Some companies offer additional benefits.

In the US, the average salary for a CRA is $70,000 per year. The range is between $60,200 and $80,900. This can vary depending on the region you work in, your education and experience levels and any additional qualifications you have.

Salaries will also be different as a freelance CRA, and this will depend on the number of clients you have and any business-related expenses you need to cover.

• Prospects. Clinical research associate. Available from: https://www.prospects.ac.uk/job-profiles/clinical-research-associate (accessed Apr 2024)
• CK Group. Clinical research associate (CRA) job profile. Available from: https://ckgroup.co.uk/candidate/job-profiles/clinical-research-associate-cra-job-profile/ (accessed Apr 2024)
• Nikolova, T. The CRA Wizard. How to become a CRA for dummies in 7 steps (or less). Available from: https://www.thecrawizard.com/how-to-become-a-cra-for-dummies (accessed Apr 2024)
• Glassdoor. Clinical research associate career. Available from: https://www.glassdoor.co.uk/Career/how-to-become-clinical-research-associate_KO14,41.htm (accessed Apr 2024)
• Coursera. How to become a clinical research associate. Published Nov 2023. Available from: https://www.coursera.org/articles/clinical-research-associate
• Walters, L. Pharmiweb.jobs. 8 ways to advance your career as a clinical research associate (CRA). Published Sept 2023. Available from: https://www.pharmiweb.jobs/article/8-ways-to-advance-your-career-as-a-clinical-research-associate-cra- (accessed Apr 2024)
• Salary.com. Clinical research assistant salary in the United States. Available from: https://www.salary.com/research/salary/alternate/clinical-research-assistant-salary (available from Apr 2024)

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Clinical research roles: how to become a clinical research associate, clinical research associate job description.

Clinical research associates (CRAs) are key actors in facilitating and ensuring successful clinical trial operations. A CRA in clinical research plays an essential role in the trial’s logistics, acting as a liaison between trial sites and the sponsor, and interacting with patients.

What is a clinical research associate?

A clinical research associate (CRA) is responsible for ensuring that clinical trials follow regulations, protocols, and Good Clinical Practice (GCP) guidelines.[ 1 ] The job description of a clinical research associate is centered on monitoring clinical trials to ensure they are conducted safely and effectively, and facilitating communication and coherence between sites and the sponsor. Their duties could include:

• Site selection: CRAs may be involved to varying degrees in selecting appropriate clinical trial sites as well as performing pre-trial site screening visits to verify their capacity to conduct the trial
• Protocol development: CRAs may help the sponsor/investigators develop the clinical trial protocol
• Study start up: CRAs assist with study start up activities, including obtaining regulatory approvals, collecting documentation, training site staff, and conducting site initiation visits
• Site visits: A core responsibility of the CRA is to visit the trial sites, both during the trial (to ensure protocol and regulatory compliance), and after the trial (to perform site close-out)
• Site monitoring: CRAs verify that sites are following the data management plan and protocols to help ensure data is accurate and complete
• Safety monitoring: CRAs may monitor patient safety throughout the trial, including adverse event reporting and serious adverse event management
• Regulatory compliance: CRAs ensure that clinical trials are conducted according to legal and ethical regulations and GCP guidelines

Other potential names for this position include clinical research monitor, clinical trials coordinator, clinical research scientist, or clinical research manager.

Qualifications: How to become a clinical research associate

To become a clinical research associate, you typically need a bachelor's degree in a relevant field such as biology, life sciences, or nursing. A degree in a field that is related to clinical research is generally preferred but is not required for all positions. Some employers may require additional qualifications, such as a master's degree or specialized certification.

In addition to formal education, experience working in the medical research industry is highly desirable. Many CRAs start their career in clinical research working under the supervision of experienced clinical research professionals.

Some of the skills needed to perform the job functions of a CRA include:

• Strong attention to detail and organizational skills
• Excellent communication and interpersonal skills
• Ability to work both independently and as part of teams
• Knowledge of the pharmaceutical and healthcare industries, health and life sciences, and clinical trial processes, regulations, and guidelines
• Analytical and problem-solving skills
• Proficiency in data management and analysis software

If you do not have a relevant degree or prior experience, there are still ways to break into the field of clinical research as a CRA. Here are a few tips:

• Look for entry-level clinical research jobs: Many companies offer entry-level clinical research associate jobs for individuals who do not have prior experience in clinical research. These positions may involve assisting CRAs with managing study activities or administrative tasks.
• Volunteer: Volunteering for clinical research organizations (CROs), research hospitals conducting trials, or other clinical research companies can provide valuable experience and demonstrate your interest in the field. Further, this experience may count as relevant work experience and could qualify you to take the ACRP CRA certification exam (see next section)

Clinical research associate certification

Several courses and clinical research certifications can help you land a CRA job. Two of the most in-demand clinical research associate certifications include SOCRA’s Certified Clinical Research Professional (CCRP) certification and the Association of Clinical Research Professionals (ACRP)’s Certified Clinical Research Associate (CCRA) certification.[ 2 ],[ 3 ] A CRA certification can help demonstrate your knowledge and skills to potential employers.

Similarly, the Certified Clinical Research Professionals Society (CCRPS) offers an Advanced Clinical Research Associate Certification (ACRAC) and course which covers clinical research protocols, clinical trials regulations set by the FDA, Good Clinical Practice (GCP), ICH guidelines, and more.[ 4 ] On a more general level, Coursera offers a specialized certification in Medical Terminology led by Rice University to help you get started on various career paths in the medical field.[ 5 ]

Where to look for clinical research associate jobs

Clinical research associates typically work for pharmaceutical companies, contract research organizations (CROs), academic institutions, or government agencies involved in conducting clinical research. They work closely with a team of clinical research professionals, including principal investigators (PIs), clinical research coordinators (CRC), data managers, and sponsors.

You may be able to find job openings directly with such companies by surveying their websites for open positions. However, you can also look for CRA jobs on job boards such as Indeed[ 6 ] or LinkedIn[ 7 ].

What is the average clinical research associate salary?

The average clinical research associate salary in the United States is around $81,826 (as of when this article was written), with a lower range of $49,052 and a higher range (senior clinical research associate salary) of around $136,499.[8] Salary will depend on multiple factors: level of experience, education, other certifications/qualifications, skillset, and the specific employer.

Clinical Research Associate job outlook

The job outlook for clinical research associates is quite positive, with the high demand for professionals in this field expected to continue. According to the Bureau of Labor Statistics, the employment of medical and health services managers, which includes clinical research associates, is projected to grow 28% between 2021 and 2031.[ 9 ]

In addition, the pharmaceutical and biotech industries are constantly developing new drugs and therapies, which must go through clinical trials before they can be approved. In the USA alone, there are currently over 400,000 active clinical trials.[ 10 ] Thus, there is high demand for professionals with the skills and knowledge to oversee these trials, ensure they are conducted safely and ethically, and optimize their success, particularly in the context of recent advances in technological adoption and new trial models. Moreover, CRA salaries have increased by an average of 15% over the past five years.[ 11 ]

Becoming a clinical research associate is a challenging yet rewarding career path requiring unique skills and qualifications. If you are passionate about medical research and want to make a difference in patients' lives, and you like working with diverse teams on large projects, this may be a promising career path for you. With the proper education, a CRA training program, and some relevant experience, you can become a vital part of the clinical research industry and contribute to the development of new treatments and therapies.

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Clinical Research Associate (CRA)

This role-based course provides the practical know-how to monitor clinical research sites effectively.

About this Course

A foundational course for individuals considering a career as a clinical research associate (CRA). The course provides broad training on the ethical, regulatory, and practical aspects of monitoring a research site. The modules explain how recent developments in clinical trial organization and conduct have changed the role of CRAs. In addition, the course details the communication and relationships among CRAs, sponsors, contract research organizations (CROs), clinical research coordinators (CRCs), and principal investigators.

Course Preview:

Language Availability: English

Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Principal Investigators (PIs), Research Administrators, Sponsors, Students

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations Independent Learner Price: $99 per person

Course Content

" role="button"> scientific concepts and research design.

This module explores how scientific principles inform study design and protocol development. It defines what qualifies as a research question and study hypothesis, lists the components of rigorous clinical research, notes some common weaknesses of different protocol designs, details the central elements of a study protocol, explores how to interpret protocols, and delineates the CRA’s role in monitoring a study site’s implementation of a protocol.

Recommended Use: Required ID (Language): 21178 (English) Author(s): Jessica Rosenbluth, MS - Syneos Health

" role="button"> Ethical and Participant Safety Considerations

This module examines the relevant national and international principles of participant protection in clinical research. It explains the ethical issues involved when working with vulnerable populations and describes the additional safeguards that should be in place to protect such subjects. The module also details the role of the study monitor in ensuring protection of participant rights in an ongoing clinical study.

Recommended Use: Required ID (Language): 21179 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Investigational Products Development and Regulation

This module explores the conception, development, testing, and approval of biomedical products and details the key stages of a biomedical product’s lifecycle. It defines the regulatory pathways for drugs, biologics, and medical devices, while describing how sponsors work with the U.S. Food and Drug Administration to gain approval for product marketing. The module provides CRAs with a working knowledge of the biomedical product lifecycle necessary to facilitate interactions between clinical research sponsors and sites.

Recommended Use: Required ID (Language): 21180 (English) Author(s): Robert Michalik, JD, RAC - RegulatoryPro Consulting

" role="button"> Clinical Study Operations (Good Clinical Practice)

This module provides an overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) guideline, with a particular focus on sections that are most relevant to the work of a CRA. The module describes how a CRA’s monitoring activities help a site comply Good Clinical Practice (GCP). The module concludes with introduction to the proposed changes found in the E6(R3) update of the ICH guideline.

Recommended Use: Required ID (Language): 21181 (English) Author(s): Chinonso Singleton, MS - LIBRE, LLC

" role="button"> Understanding the Clinical Monitoring Plan

This module covers the roles and responsibilities of study monitors and details a monitoring plan's creation, purpose, and contents. It outlines risk-based and remote monitoring approaches and contrasts these with an earlier traditional model for monitoring. The module also focuses on the essential components of a monitor’s communication with investigators, study staff, and sponsors.

Recommended Use: Required ID (Language): 21182 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Implementing the Monitoring Plan

This module describes the preparation for and conduct of different site visits. It identifies the central actors involved and the common interactions among them. The module also details the key components of a visit follow up.

Recommended Use: Required ID (Language): 21183 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Emerging Clinical Trial Methods and Technologies

This module defines the purpose and use of emerging technologies for study management and data collection. It describes how these technologies enhance risk-based monitoring (RBM). In addition, the module discusses how decentralized clinical trial (DCT) modules are shaping the future of clinical trial conduct.

Recommended Use: Required ID (Language): 21184 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Data Management and Informatics

This module defines the core aspects of data management, describes quality clinical trial data, defines data-related milestones, and connects data processes to related systems and software. The module also outlines selected data-handling processes and provides CRAs with information on operational activities to maintain data quality at their assigned clinical trial sites.

Recommended Use: Required ID (Language): 21185 (English) Author(s): Chinonso Singleton, MS - LIBRE, LLC

" role="button"> Leadership, Communication, Professionalism, and Teamwork

This module describes some principles and practices of leadership, communication, professionalism, and teamwork related to clinical research. It describes how a CRA can leverage soft skills to effectively manage stakeholder relationships in a clinical trial.

Recommended Use: Required ID (Language): 21186 (English) Author(s): Clareece West, BSc - West-Fenn Enterprise, LLC

" role="button"> Who should take the Clinical Research Associate course?

Learners who wish to gain foundational knowledge of clinical research site monitoring should take this course to prepare for a career as a clinical research associate (CRA). The course is ideal for clinical research coordinators (CRCs) looking to transition to becoming CRAs and for organizations looking to onboard new CRAs.

Suggested audiences include new Clinical Research Associates, Clinical Research Coordinators, Contract Research Organizations, Faculty, Principal Investigators, Research Administrators, Sponsors, and Students.

" role="button"> Why should someone take the Clinical Research Associate course?

This role-based course provides the practical know-how to monitor clinical research sites effectively. It provides broad training on the ethical, regulatory, and practical aspects of monitoring a research site. The modules explain how recent developments in clinical trial organization and conduct have changed the role of CRAs. In addition, the course details the communication and relationships among CRAs, sponsors, clinical research coordinators (CRCs), and principal investigators.

" role="button"> How does the Clinical Research Associate course complement other CITI Program Courses?

Clinical Research Associate is a helpful complement to CITI Program’s Clinical Research Coordinator (CRC) Foundations and Clinical Research Coordinator (CRC) Advanced courses. It provides the next set of tools required for research monitors. CRCs looking to become CRAs will find that Clinical Research Associate is essential to making this professional transition.

" role="button"> What are the required and supplemental modules?

The modules for the Clinical Research Associate course are:

• Scientific Concepts and Research Design
• Ethical and Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (Good Clinical Practice)
• Understanding the Clinical Monitoring Plan
• Implementing the Monitoring Plan
• Emerging Clinical Trial Methods and Technologies
• Data Management and Informatics, and
• Leadership, Communication, Professionalism, and Teamwork

The course is designed to be completed sequentially through all nine modules (we recommend they are set as “required”).

" role="button"> Is this course eligible for continuing medical education credits?

The course does not currently have CE/CME credits available.

" role="button"> How long will the course take a learner to complete?

This course consists of nine modules. Each module contains detailed content, a quiz, images, supplemental materials, and case studies.

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means it could take around 4.5 to 5.5 hours to complete.

Related Content

CRC courses focus on key topics essential to the conduct of clinical research. They are specifically tailored to the needs of clinical research coordinators.

Discusses the importance of CRA soft skills in building productive relationships with sites and sponsors.

Discusses the process and content of a CRA’s interim monitoring visit.

Details ways to produce productive partnerships between clinical research associates and clinical research coordinators.

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Home » Blog » What Is a CRA?

What Is a CRA?

Table of Contents

A clinical research associate (CRA) is a professional who oversees all aspects of clinical trial conduct. They oversee clinical trials to test drugs/medical devices/biologics/or in vitro diagnostics for their effectiveness, risks and benefits to ensure they are safe to allow on to the market.

CRAs are also known as clinical trial monitors or clinical monitors. A CRA may be involved in some or all stages of the clinical trial depending on the type of position and the employer a CRA work for.

Type of CRAs

In-house cras.

CRAs who work for a sponsor company are called in-house CRAs. An in-house CRA may be overseeing all aspect of clinical trial conduct, from planning to clinical study report (CSR) generation for submission to regulatory bodies. Below are some job functions of an in-house CRA:

• Designs study documents such as, study designs, synopsis, site specific protocols, informed consent forms, case report forms, site study procedure manuals and project tools, monitoring plans, and tracking tools, clinical study reports, budget and contract negotiation.
• Performs independent monitoring of sites including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits.
• Maintain frequent contact with and work effectively with investigators and coordinators.
• Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.
• Review and resolve discrepancies in clinical data with clinical sites or through a contract research organization (CRO) .
• Low amount of travel may be required (e.g. up to 25-30%).

Regional CRAs / Home-based CRAs

CRAs who work independently from home are called regional CRAs or home-based CRAs. Regional or home-based usually don’t handle planning and preparation of clinical trials. They generally handle the monitoring function and oversee trial conduct. Thus, they can work from home and they usually travel quite a bit more than their in-house CRA colleagues.

• conducting site pre-qualification
• monitoring visits
• close-out visits
• Review and resolve discrepancies in clinical data with clinical sites.
• High amount of travel may be required (e.g. up to 75-80%).

CRAs Who Work For a CRO

CRAs who work for a contract research organization (CRO) can be either in-house CRA or monitoring CRA. They usually work out of a CRO’s office.

As the goal of the CRO is to provide full range clinical trial services to sponsor companies, CRAs who work for a CRO may be called upon to perform in-house or monitoring functions depending on the project and client’s needs.

One note to mention is that CROs are sensitive to the economic cycles. When the economy is good, CROs may hire a lot of CRAs to meet the higher numbers of clinical trial demands. When the economy is bad, CROs may turn around and lay off CRAs as work demand reduces.

In addition, CRAs who work for a CRO are expected to work hard. They may be assigned to oversee multiple studies with high number of sites (>10 sites). That being said, a CRA position at a CRO is usually a good way for a new CRA to gain experience. Another benefit in working at a CRO is gaining exposure to a variety of therapeutic areas that may enhance a CRA’s credential and career progression.

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How to become a clinical research associate (CRA)

Clinical research is an important step in developing and evaluating new medical products. For people with qualifications or experience within life sciences , a career in clinical research can offer many rewarding, interesting and varied opportunities and career paths . With the demand for new prevention methods and treatments ever increasing, clinical research associates are needed by pharma, biotech, medical device companies and CROs around the world. Here are some things to consider if you’re looking to kick-start a career in clinical research and how to become a clinical research associate:

What is a clinical research associate?

'A clinical research associate (CRA) is someone who monitors the running of clinical trials. A CRA may be involved in some or all stages of the clinical trials process depending on the type of position or the employer.

What are the responsibilities of a clinical research associate?

Typically, the key responsibilities of a CRA will include monitoring study sites and clinical activities, updating study documentation, maintaining clinical data systems and coordinating research procedures.

If you are a field-based CRA, you will spend most of your time travelling to different locations, dealing with medical professionals in trial centres, healthcare practices, or hospitals. The remainder of your time may be spent either office-based or working from home, but this will depend on the company. Some companies will have in-house CRA roles who just focus on document review and management and will make site visits only occasionally.

What is the demand for clinical research associates?

Driven by a rise in the number of healthcare facilities, increasing healthcare expenditure, technological and research capabilities, and an aging population, the need for new treatments has increased exponentially in recent times. This has led to a rise in the number of companies hiring for new clinical research jobs and this is likely to keep gaining momentum in the years to come.

What qualifications or training do I need to get a clinical research associate job?

A degree in a life science or other health-related discipline is usually needed to start a career in clinical research. However, there are courses and training available that can help you get a foot in the door if you haven’t got the desired qualifications.

Qualifications:

Although not usually necessary, a Master's degree (MSc. or equivalent) or a PhD can be advantageous and could give you valuable experience in clinical research. A relevant PhD can also be beneficial, as some companies will see this as relevant work experience and count it towards reaching promotions to more senior positions.

Certifications:

The Association of Clinical Research Professionals (ACRP) offers a certification exam to become a Certified CRA. Even though, for most CRA roles, this is not a requirement, being CCRA certified is a real advantage. The exam covers everything a CRA will need to know from scientific concepts and research design to product development and regulation, to data management.

There are lots of courses out there that can provide you with a detailed understanding of what it takes to a be CRA. Before you sign up to anything, make sure it is a recognised training course that is recommended by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

How do I get the right experience for a clinical research associate job?

Getting your first job in clinical research can be challenging, and many graduates at the start of their clinical research career can become frustrated by the 'catch 22' scenario: they can't find work because of a lack of experience and they can't get experience because they can't find work.

Without relevant work experience, you will be more likely to secure a job as a clinical trials assistant (CTA). A CTA role will help support all processes of the trial and give you the required experience to move into a clinical research assistant role.

Generally, larger companies are far better equipped to take-on inexperienced graduates and are more likely to offer programmes such as graduate assessment days and internships. Research who the top pharmaceutical companies , medical device manufacturers and contract research organisations are, and look out for opportunities on their career websites. Their social media pages are also great places to find out about graduate programmes, so keep a close eye on them too.

You might be able to gain experience by working on academic projects or working within a healthcare body. Although these are good ways to gain experience, moving into a commercial environment later can be quite different and you might have to take a more junior position with a lower salary than you are used to.

Tips for applying to clinical research jobs            

Even with all the relevant qualifications, skills and experience that you need to become a clinical research associate, there can still be challenges in landing your perfect clinical research job . A few simple changes to your approach can give your CV a better chance of success .

Be realistic

Be realistic about the types of jobs that you can attain. If you don’t have industry experience, you are unlikely to be hired for anything above an entry level role. Don't apply to senior CRA jobs or clinical project manager roles unless you have been working as a CRA for some time already and have the required experience. Save yourself the time and effort in making lots of speculative applications and take a more targeted approach.

Highlight your relevant experience

If you are applying for a clinical research associate job , ensure that you read each job description carefully and highlight on your CV the relevant experience that matches the specific description. Your cover letter should be personalised to the specific company and describe why you want to work for that company and which of your skills match the specific requirements of the role. Employers and life sciences recruitment consultants are looking for the most relevant applications and will readily discard those that have put little effort into personalising it.

Make sure you network

Remember, not every company will advertise all its vacancies so you should consider other approaches too. Networking with recruiters and hiring managers and uploading your CV to a database are two great ways that employers and recruiters with CRA jobs can find you.

What are the different career paths you can take?

There are a variety of ways to progress your career in clinical research , with pharma, biotech, and medical device companies and CROs all offering opportunities. Roles will vary from company to company but typically CRAs will progress to be a senior clinical research associate. With the right experience, CRAs will have the potential to progress all the way to clinical director or even VP level.

Once a CRA has reached senior level, there are typically three main routes a career in clinical research can take. You will either be a manager of the trial process, a manager of people or a project manager.

Clinical trial management:

Usually responsible for managing, coordinating, and overseeing various aspects of the trial. Typical duties will involve supervising staff, implementing study tools and documents, overseeing trial budgets and providing strategic input into trials.

Clinical team management:

Responsible for acting as the direct line manager to associates. Clinical team managers will manage and support team members, ensure staff are trained effectively, review the effectiveness of business processes and plan professional development activities.

Clinical project management:

Involved with the planning and directing of clinical trials and is also responsible for evaluating clinical data. Day-to-day tasks include, maintaining study records, ensuring activities are being delivered on time and on budget, interpreting study data and developing trial plans.

Are you already a CRA professional or looking to start your career in clinical research? We might have something that is the right fit for you. We are looking for experienced professionals for a broad and extensive range of clinical research positions. Take a look at our latest clinical research jobs and apply today.

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Scientists, researchers, and doctors make discoveries about drugs, surgical procedures, behavioral therapies, or medical devices through their work in laboratories and healthcare settings. This is only the beginning of the journey for pharmaceuticals, therapies, and devices, as bringing the findings from the lab to the street requires a vigorous scientific process known as a clinical trial. Clinical research associates (CRAs) are the professionals responsible for ensuring that clinical trials move forward following established guidelines and regulations for ethics, safety, and reporting.

Clinical research associates, also known as “monitors,” work on behalf of sponsors funding clinical trials for the new or existing drug, device, surgery, or behavioral intervention. Working directly for the sponsor or through a contract research organization, the main task of a CRA is to monitor the progress of an ongoing clinical trial.

Through in-person site visits or remote monitoring systems, a CRA serves as the central point of contact between a sponsor and testing sites; ensures that the trial is being administered per approved protocols; verifies that the clinical trial is being conducted ethically at all sites; and confirms the validity and accuracy of all data being collected and reported at test sites.

In addition to reading, interpreting, and understanding medical technology, clinical research associates must have excellent interpersonal and communication skills. The ability to understand best clinical practices, design protocols, and data standards requires CRAs to have outstanding attention to detail, analytical skills, and the capacity to deliver constructive feedback to participating research sites on their performance.

Although not a requirement, many CRAs travel between multiple research sites for study oversight, which may require a valid driver’s license, the physical capacity to travel, and/or willingness to fly or drive regularly.

This detailed guide explores the education and credentials required to become a clinical research associate (CRA).

Arizona State University

Johns hopkins university (aap), university of west florida, steps to become a clinical research associate (cra).

The pathways to becoming a clinical research associate are numerous and available to anyone with a high school diploma or higher. While formal education is not technically required to enter the field, having a bachelor’s degree or higher can make potential candidates much more competitive.

Certification in the field is also not required, but obtaining certification from the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP) can result in more opportunities and even more competitive salaries.

Finally, all aspiring CRAs are advised to check out the International Conference on Harmonisation’s (ICH) guidelines for Good Clinical Practice (GCP) to get a feel for the professional expectations and responsibilities.

Here is how to become a CRA depending on one’s level of education. Please note that in the United States, there are two major certification bodies for CRAs: the Society of Clinical Research Associates (SOCRA) and the Association of Clinical Research Professionals (ACRP). Each pathway includes the eligibility requirements to pursue credentialing through either of these entities.

PATH 1: Earn a High School Diploma and Gain Experience

Perhaps the most strenuous route to this career is becoming a certified CRA with a high school diploma and between 3,000 and 3,500 hours of qualifying work experience (depending on the certification entity).

These candidates often start out in support positions assisting a more experienced or certified CRA with mundane tasks. An entry-level worker can earn increased responsibilities through a demonstrated capacity to learn the regulations, protocols, and ethical considerations. To qualify for the following CRA certification exams, high school graduates must:

SOCRA Category 1

• Complete two full-time years of CRA work within five years, or 3,500 hours of part-time work

ACRP CCRA (Certified Clinical Research Associate)

• Complete 3,000 hours performing essential duties
• Submit a resume documenting and demonstrating job performance

Please note that in some cases, additional education can be used to substitute for work experience hours. Please see credentialing websites for details.

PATH 2: Earn an Associate Degree and Gain Experience

Depending on the program, an associate’s degree of applied science (AAS) in clinical research can be a standalone degree or a stepping-stone to a bachelor’s or master’s. Licensed vocational or practical nurse (LVN or LPN) programs are designed specifically for practical, job-ready skills and may qualify aspiring CRAs for the ACRP certification.

Similar to the path taken by those with a high school diploma, having an associate degree, LPN, or LVN can open the door to some entry-level jobs in the industry. At this level, some prospective CRAs assist more experienced CRAs or some engage independently in entry-level tasks related to study monitoring. Those working as CRAs with an associate’s degree, LPN, or LVN can qualify for certification after working a certain number of hours in the field.

To qualify for the following CRA certification exams, associate degree graduates must:

SOCRA Category 2

• Hold a “clinical research” degree
• Complete one full-time year as a CRA or 1,750 hours part-time

ACRP Option 2 (Also for LVN, LPN)

• Hold a “clinical research degree” or complete 1,500 hours performing essential duties

PATH 3: Earn a Bachelor’s Degree and Gain Experience

Most entry-level clinical research associate positions require candidates to have a bachelor’s of science (BS) in a health-related field from an accredited four-year university. In some cases, programs are designed to add practical hours needed to qualify for certification tests.

Those interested in becoming a CRA can study nursing, health sciences, biological sciences, clinical research, clinical research administration, clinical research management, medical technology, or life sciences, among many other subjects. Because many entry-level positions are looking for those with previous work in the field, those earning a BS should seek internships, part-time work, and/or fellowships involving participation in research, if possible.

To qualify for the following CRA certification exams, bachelor’s degree graduates must:

SOCRA Category 3

• Hold a “clinical research” undergraduate degree

ACRP Options 1 & 2

• Complete 3,000 hours performing essential job duties or 1,500 hours of equivalent work experience requirements through ACRP certifications or approved clinical research degree programs accredited by the Council for Higher Education

PATH 4: Earn a Master’s Degree for Opportunities in Management

A master’s program in clinical research is generally designed for those already working as CRAs to expand their skills or to advance into management or supervisory roles within the field. However, for those with non-health science bachelor’s degrees who want to become CRAs, seeking a master’s of science in clinical research or a master’s of science in clinical research management could be a pathway to breaking into the field.

Because many of these programs are offered online, earning a degree is possible for even those students who need full flexibility of schedule to complete the degree. Although requirements for admission into master’s programs vary, those looking to gain admission into a master’s of science for clinical research commonly need the following:

• A bachelor’s degree
• Official transcripts demonstrating specific coursework in science
• A statement of purpose
• Letters of Recommendation or Reference
• A resume or CV
• An application fee
• TOEFL or IELTS scores (international students only)

Clinical Research Associate (CRA) Degree Programs

There is a range of formalized training programs that prepare professionals for this key role in ensuring the safe, and ethical development of medical technologies. Below you will find examples of programs at a range of educational levels available to those interested in a career as a CRA.

Durham Tech – AAS Program

Durham tech, located in Durham, North Carolina, offers a 71-credit hybrid on-campus and online clinical trials research associate (CTRA) associate of applied science (AAS) program. Durham’s CTRA AAS prepares graduates to work on any side of clinical research in an assistant’s role.

While most programs require the student to attend on-campus courses, there are several courses that are offered completely online. The program takes 20 to 21 months and includes coursework in research site management; clinical research management; research protocol design; an introduction to ethics; anatomy and physiology; an introduction to clinical data; pathophysiology; and clinical research terminology.

Graduates of the program may be eligible to sit for national certification examinations and will be prepared for opportunities at medical centers, pharmaceutical industries, hospitals, research facilities, clinics, physicians’ offices, and device companies.

• Location: Durham, NC
• Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC); Commission on Accreditation of Allied Health Education Programs (CAAHEP)
• Expected Time to Completion: 20 to 21 months
• Estimated Tuition: $5,396

Washington University in St.Louis University College – BS, MS, Certificates

Washington University in St. Louis, Missouri, has various degree options for CRAs at all stages of their career to work as monitors. Students can enhance their current skills and knowledge in clinical research management, as well as gain a deep mastery regarding how to best move clinical research forward in an ethical, compliant, and safe way.

Those with at least six units of transferable coursework qualify to apply to the 120-credit-hour bachelor of science in clinical research management to start their careers. Anyone with any educational background can pursue University College’s 21-credit undergraduate certificate in clinical research management to enhance career skills or make a resume more competitive.

Students who already have a BA or BS also have options at Washington University. Experienced professionals in the clinical research field who wish to seek formalized training can earn a 21-credit advanced certificate in clinical research management or a 30-credit master of science (MS) in clinical research management. Those with a non-healthcare bachelor’s degree who wish to become high-level CRAs can up their skills and knowledge by choosing the combined bachelor’s and master’s degree options.

Although the coursework in each program varies to suit the level of education, themes across all the programs include the fundamentals of clinical research management; research ethics and regulatory affairs; compliance, legal and regulatory issues; and data and information management in health sciences.

• Location: St. Louis, MO
• Accreditation: Higher Learning Commission (HLC)
• Expected Time to Completion: BS (up to 48 months); certificate (12 months); MS (24 months)
• Estimated Tuition: Undergraduate courses ($695 to 895 per credit); Graduate courses ($665 to 995 per credit)

Barnett International – Online Seminar

Designed for CRAs with two years of experience or less, this online clinical research associate onboarding program by Barnett International prepares entry-level employees to monitor clinical trials at high levels appropriate to industry standards.

Over ten weeks of synchronous online coursework lasting three hours per week, participants will learn topics including informed consent, investigational product accountability, safety definitions and reporting requirements, and regulatory compliance and quality assurance: audits and inspections. Participants receive 30 hours (3.0 CEUs) of continuing education credits.

• Location: Needham, MA
• Accreditation: Accreditation Council for Pharmacy Education
• Expected Time to Completion: Ten weeks
• Estimated Tuition: By Early Bird Deadline ($1,795); After Early Bird Deadline ($1,995); June 10 is the early bird deadline

Continuing Education for Clinical Research Associates (CRAs)

Both CRA certification bodies require continuing education to maintain active certification status.

SOCRA requires recertification every three years. It calls for 45 hours of CE to be completed over the course of the first three years beyond passing the initial test. Twenty-two CE units must be related to clinical research; the remainder can be in the professional or therapeutic area in which one works or specializes. In addition, those looking to maintain or renew certification must complete a “recertification continuing competence learning module.”

The ACRP expects certified CRAs to engage in continuing education (CE) and continuing involvement (CI) to maintain certifications. Continuing education should include coursework in research and healthcare, and continuing involvement requires candidates to engage in activities such as authorship, participating in investigator meetings, or working as a peer reviewer, among other opportunities. Notably, ACRP utilizes an ongoing point system for professionals to maintain their certifications.

CRA Career and Salary

Clinical trials and the objectivity they bring to advances in treatment are extremely important. In an increasingly globalized society, diseases spread across borders, and in an age of increased antibiotic resistance, new ways to fight bacteria will be needed. Furthermore, with an aging U.S. population comes increased rates of chronic conditions and the subsequent reliance on pharmaceuticals to improve people’s quality of life.

It’s not surprising that the Bureau of Labor Statistics (2022) predicted a 7 percent increase in openings for medical and clinical laboratory technicians between 2021 and 2031, much more than the average growth anticipated across all U.S. occupations during that same decade (5 percent). As far as the salaries are concerned, here are the salary percentiles for clinical laboratory technologists and technicians in the US ( BLS May 2022):

Lastly, while the BLS doesn’t track salaries for CRAs, PayScale.com (June 2023)—a site that relies on self-reported data—found that the median annual salary for a CRA was $72,393. Among the 1,391 CRAs reporting their annual salaries, Payscale found these percentiles:

• 10th percentile: $48,000
• 50th percentile (median): $72,393
• 90th percentile: $101,000

Specialized skills in CRA that increased salaries included medical devices (37 percent pay increase over average), team leadership (35 percent), and writing procedures & documentation (20 percent).

Years of experience, predictably, also have an impact on salary. Entry-level CRAs earn 15 percent below the average, while experienced CRAs (ten to 19 years) earn 16 percent above the average and late-career CRAs (20+ years) earn 25 percent above the average.

It is important to note that these figures also vary based on the data source. For illustration, Indeed.com (June 2023) found an average annual salary of $80,957 among United States clinical research associates.

Becca Brewer is building a better future on a thriving earth by healing herself into wholeness, divesting from separation, and walking the path of the loving heart. Previously to her journey as an adventurer for a just, meaningful, and regenerative world, Becca was a formally trained sexuality educator with a master of education.

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How To Become A Clinical Research Associate - A New Scientist Careers Guide

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• Career guides

What does a clinical research associate do?

Clinical research associates (CRAs) are responsible for running clinical research, which consists of trials designed to test new or current drugs/immunisations and analyse their effectiveness, risks, benefits and safety of use. 

CRAs play an important role in the healthcare industry and public health development by helping to design and test new medications, vaccinations and other therapeutic agents.

CRAs can be involved at any stage of a drug development trial, including planning, coordinating and supervising. It is their responsibility to ensure a drug has been appropriately examined and all its risks have been evaluated before it is released to be used publicly.

CRAs most commonly work for pharmaceutical companies or contract research organisations. They might also have to spend some time working in a hospital setting to collect data about the drugs they are analysing. They might also work for universities or public/global health organisations. 

As a CRA, you may have a range of responsibilities depending on your employer, project and level of experience. Typically, CRAs will need to complete tasks such as:

• Designing and writing trial protocols and standard operating procedures
• Presenting protocols and procedures to steering committees
• Designing data collection forms
• Requesting ethics approvals and working with ethics committees
• Liaising with staff conducting the trials, such as doctors or consultants
• Training local staff based on trial-specific standards
• Monitoring operations during clinical trial data collection
• Collecting completed data collection forms
• Performing data management and analysis, and discussing the results
• Closing trials and finalising reports with the help of a statistician

CRAs will work in a team of other research professionals, including contract organisation or sponsor staff, principal investigators and clinical research coordinators.

How to become a clinical research associate

To become a CRA, you need to obtain a degree in medical sciences, life sciences or nursing. This can be in subjects such as biomedical science , anatomy, physiology, immunology , pharmacology or broader degree subjects like chemistry and biology .

Alternatively, you can access a career as a CRA by acquiring a higher national diploma (HND). This is a qualification equivalent to the second year of a bachelor’s degree. HNDs can be beneficial to those who want to enter more practical fields, clinical research included.

Occasionally, you can enter a CRA role from an administrative background. For instance, if you begin working as a clinical trials administrator/assistant and decide you would prefer the role of a CRA, you can complete additional qualifications to do this. However, this will take some time and can be difficult.

Most employees view undergraduate qualifications as sufficient, but in some cases a postgraduate degree may be beneficial. Master’s degrees and PhDs can gain you an advantage when applying for competitive positions, and help you gain more experience in research .

Work experience is key to securing a clinical research job. You can get this at any point in your training, and some universities may help with this. The types of work experience most useful for a CRA role include:

• Academic research
• Pharmaceutical research (e.g. via a pharmaceutical industry placement during your degree)
• Laboratory work
• Nursing or care work
• Work in a pharmacy or medical sales
• Other, similar activities

How long does it take to become a clinical research associate?

Becoming a CRA will usually take around three to four years, depending on the access pathway you choose.

If you opt to complete an undergraduate degree, this can take three to four years. You can then apply to job positions as a CRA straight away. However, if you don’t have sufficient work experience, you may need to start at a lower-level position such as a more administrative job. From here, you can gain more experience and reapply for a higher-level position.

If you choose to obtain a HND qualification, this will take two years. Provided you have sufficient experience, you can then apply for a graduate post as a CRA, but again you may need to gain some extra experience/qualifications in some cases.

If you opt to do a postgraduate degree first, this may take an additional one to three years depending on whether it is a master’s degree or a PhD. Many CRA job positions also allow for completion of postgraduate qualifications alongside the job.

A day in the life of a clinical research associate

Most CRAs work about 40 hours a week, during weekdays. There may be an out-of-hours commitment, for instance if working in a hospital setting monitoring a new drug, but this is dependent on your employer and role.

CRAs can work on multiple trials at a time, in multiple different sites. This will depend on the complexity of each trial and what stage each of the trials is in. Therefore, the role may entail some travelling at times, while other times most of your work will be concentrated on one site.

As a CRA, you will carry out a wide variety of tasks. Some days may be spent writing reports. On other days, you will work on site with healthcare staff , or you might go into your office and attend meetings.

No matter your experience level or how senior your role is, as a CRA, you will need to work in a team with other research and healthcare professionals. You will be communicating with research nurses, doctors, health consultants, investigators and managerial and administrative staff from the company requesting the trial.

The role requires good communication skills, as well as good time management and organisation skills, because carrying out a few different studies at once may mean some tasks clash with one another and you need to prioritise the most important ones.

Clinical research associate: Career options

As with most clinical roles, CRAs undergo lots of continuing professional development (CPD) within their role. There are many training courses available to CRAs to build on their existing skills and develop new competencies.

Most training courses are organised by external bodies, and many are paid for by the employer. One of the organisations that runs training courses is the Institute of Clinical Research (ICR). It provides training in areas such as effective project management for clinical trials and advanced clinical trial monitoring, among several others.

The ICR also offers certificates and a diploma that you can complete to evidence your skills in clinical research. Becoming an ICR member and obtaining courses and qualifications from it can also be beneficial to career development, as you will meet other prominent professionals in your field through interacting with this organisation.

You can also opt to complete a postgraduate qualification, such as a PhD or master’s degree in several different areas, including clinical research and clinical pharmacology .

As mentioned, you may need to climb up the professional ladder to become a CRA, and many people start off as clinical trial administrators or junior CRAs. Within these roles, you might complete tasks such as handling documentation and correspondence or helping to set up trial sites. 

From here, you can move on to becoming a senior CRA as you gain experience. At this point, you will have more advanced responsibilities, such as project management of whole trials and designing case report forms.

If you develop sufficient experience and gain contacts in the field, there is a possibility of self-employment if you want to become a freelance CRA. 

Salary: How much does a clinical research associate earn in the UK and US?

In the UK, starting salaries for CRAs range between £26,000 and £34,000 per year. As a more senior CRA, you might earn between £35,000 and £50,000, and in the most senior positions involving managerial tasks, you might earn upwards of £55,000.

Salaries will vary between regions and employers, as well as depending on your level of experience and responsibilities. Some companies offer additional benefits.

In the US, the average salary for a CRA is $70,000 per year. The range is between $60,200 and $80,900. This can vary depending on the region you work in, your education and experience levels and any additional qualifications you have.

Salaries will also be different as a freelance CRA, and this will depend on the number of clients you have and any business-related expenses you need to cover.

• Prospects. Clinical research associate. Available from: https://www.prospects.ac.uk/job-profiles/clinical-research-associate (accessed Apr 2024)
• CK Group. Clinical research associate (CRA) job profile. Available from: https://ckgroup.co.uk/candidate/job-profiles/clinical-research-associate-cra-job-profile/ (accessed Apr 2024)
• Nikolova, T. The CRA Wizard. How to become a CRA for dummies in 7 steps (or less). Available from: https://www.thecrawizard.com/how-to-become-a-cra-for-dummies (accessed Apr 2024)
• Glassdoor. Clinical research associate career. Available from: https://www.glassdoor.co.uk/Career/how-to-become-clinical-research-associate_KO14,41.htm (accessed Apr 2024)
• Coursera. How to become a clinical research associate. Published Nov 2023. Available from: https://www.coursera.org/articles/clinical-research-associate
• Walters, L. Pharmiweb.jobs. 8 ways to advance your career as a clinical research associate (CRA). Published Sept 2023. Available from: https://www.pharmiweb.jobs/article/8-ways-to-advance-your-career-as-a-clinical-research-associate-cra- (accessed Apr 2024)
• Salary.com. Clinical research assistant salary in the United States. Available from: https://www.salary.com/research/salary/alternate/clinical-research-assistant-salary (available from Apr 2024)

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Accreditations and Memberships

Accre - clinical research professionals.

CCRPS CRA Certification and CRC Certification is accredited by The Accreditation Council for Clinical Research Education (ACCRE) in June 2019 Code: 463-03-005-GPC08

ACCRE accredits the professional program in Clinical Research leading to the Certificate of Clinical Research. Evaluation and accreditation of this program is in accord with standards and guidelines for the professional program in Clinical Research leading to the Certificate of Clinical Research, adopted June 14, 1997 and effective July 1, 2000. Clinical Research education is in the process of transition as reflected by a corresponding change in accreditation standards.

The ACCRE is recognized for the accreditation and pre-accreditation of professional programs in Clinical Research by the biotechnology and pharmaceutical industries. ACCRE accreditation serves to establish eligibility for participation in a variety of biopharmaceutical industry funded programs, not including eligibility for Title IV Programs, Higher Education Act, 1965, as amended.

For the public, accreditation assures conformity to general expectations of the profession and identification of colleges and schools of Clinical Research which have explicitly undertaken activities directed at improving the quality of their professional programs, and are carrying them out successfully. Accreditation also assures improvement in the professional services available to the general public in that accredited programs are expected to modify their requirements to reflect advances in knowledge and practice.  For students and prospective students, accreditation provides an assurance that a program has been found to provide satisfactory educational preparation for practice in the field

For institutions of higher education, accreditation provides a framework for self-evaluation and improvement as well as opportunity for external review and counsel. Accreditation also provides a basis for the decision-making of private and public agencies in the awarding of grants, scholarships and loans.  For the profession, accreditation provides a means for practitioner participation in the setting of requirements for preparation to enter the profession.

MSA-CSS - Candidate for Accredited Career Institution

CCRPS is a candidate undergoing a 1 year intensive study for approval to be a federally recognized career and technical institution. MSA-CSS accredited postsecondary, non-degree granting career and technical institutions may use their Middle States accreditation to establish eligibility to participate in federal Title IV student loan programs for adult students (FAFSA, federal student funding). The Commission on Secondary Schools is now recognized by the U.S. Department of Education as a gatekeeper for eligibility for Title IV funding for postsecondary, non-degree granting institutions and distance education throughout the United States.

ICE Organizational Membership

An association, certifying organization, consumer group, or government agency

Joint Accreditation - Physicians, Nurses, Pharmacists, Healthcare Providers

Advanced Clinical Research Professionals

Jointly provided by Postgraduate Institute for Medicine and Certified Clinical

Research Professionals Society (CCRPS)

Release date: July 14, 2020

Expiration date: September 8, 2025

Estimated time to complete activity: 17.5 hours

Contact PIM

Target Audience

This activity is intended for physicians, nurses, pharmacists, and professionals engaged in

care of patients in clinical trials.

Educational Objectives

After completing this activity, the participant should be better able to:

Describe the ICH GCP protocol including FDA 21 CFR, E2A, 5,5 E6, and Ethics

Explain the Quality Monitoring process including designing trials, site visits, monitoring visits, close out visits, protocols, and reporting violations. 

Outline the process and professional roles involved in audit and inspections.

Appropriately detect and report misconduct and fraud.

Apply concepts of clinical research roles in a multiple choice examination.

Dr.Kamaljit Tiwana, Diedre Clarke, Sahar Khan

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy.  PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.

Faculty have nothing to disclose.

The PIM planners and others have nothing to disclose. The CCRPS planners and others have nothing to disclose. 

Method of Participation and Request for Credit

In order to obtain your CME/CE certificate, please follow the steps below at the conclusion of the activity:

Go to www.cmeuniversity.com

Login or Create a New Account (will take less than 1 minute)

If you receive a message when creating a new account that “the email you entered is already in use”, please click the Forgot my Username or Password link to have your Username and Password sent to you via email

After logging in, you may be asked to verify/update your information; after doing so, click Save at the bottom of the page

Type in 15592 at the top of the page, “Find Post-Test/Evaluation by Course”, and click enter

Click on the activity title when it appears

Choose the type of credit you desire

Complete the online assessment

Receive an immediate CME/CE Certificate to download and/or print for your files

For Pharmacists: Upon completion of the online evaluation, your credit will be submitted to CPE Monitor. Pharmacists have up to thirty (30) days to complete the evaluation and claim credit. Please check your NABP account within thirty (30) days to make sure the credit has posted. 

If you have questions regarding the certification of this activity, please contact PIM via email at [email protected]. 

Joint Accreditation Statement 

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and Certified Clinical Research Professionals Society (CCRPS).  Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Credit Designation

Physician Continuing Medical Education

The Postgraduate Institute for Medicine designates this enduring material for a maximum of 17.5 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 17.5 contact hours.

Continuing Pharmacy Education

Postgraduate Institute for Medicine designates this continuing education activity for 17.5 contact hour(s) (1.75 CEUs) of the Accreditation Council for Pharmacy Education. 

(Universal Activity Number - JA4008162-9999-23-300-H99-P)

Type of Activity: Application

Policy on Privacy and Confidentiality  

Please see final activity for the policy on privacy and confidentiality that relates to this internet activity.   

Computer System Requirements

The most recent version of one of the following browsers: Chrome, Firefox, Safari, Microsoft Edge

Javascript enabled

Graphic and audio output capability

Broadband internet connection with a minimum speed of 5Mbps (recommended)

TLS 1.2 supported by your web browser

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA.  The planners of this activity do not recommend the use of any agent outside of the labeled indications.  The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners.  Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development.  The information presented in this activity is not meant to serve as a guideline for patient management.  Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient's conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.

TransCelerate BioPharma - ICH GCP

Recognizes CCRPS Certification as Evidence of GCP Training. CRA, CRC, and ACRP-F certification available by CCRPS meet the criteria for GCP training. We are recognised by the 20 major TransCelerate associated BioPharma companies through mutual-recognition to prevent overlap in GCP training. Criteria consisted with GCP training include:

(1.24) Definition of ICH GCP

(1.34) Definition of Investigator

(1.56) Definition of Subinvestigator

(1.53) Definition of Sponsor

The Principles of ICH GCP

13 ICH GCP Principles

(4.1) Investigator Qualifications and Agreements

(4.2) Adequate Resources

(4.3) Medical Care of Trial Subjects (4.4) Communication with IRB/IEC (4.5) Compliance with Protocol (4.6) Investigational Products (4.7) Randomization Procedures and Unblinding (4.8) Informed Consent of Trial Subjects (4.9) Records and Reports (4.10/4.13) Progress Reporting/ Final Reports (4.11) Safety Reporting (4.12) Premature Termination or Suspension of Trial

(4.10/4.13) Progress Reporting/ Final Reports

(4.11) Safety Reporting (4.12) Premature Termination or Suspension of Trial

CCRA Certification

Ccra® (certified clinical research associate) is a credential formally recognizing clinical research professionals with experience monitoring and supervising the conduct and progress of clinical trials on behalf of a sponsor., this trusted mark of excellence in clinical research is awarded to clinical researchers who have demonstrated proficiency of specific knowledge and skills by passing the standardized ccra® certification exam., read the latest acrp ccra® blog, “spotlight on the clinical research associate career pathway and resources” >.

Apply for Your Exam

Clinical research professional with 3,000 hours of verifiable work experience are eligible to sit for the CCRA ® Exam. Complete eligibility criteria is defined in the Academy’s  policy manual .

What qualifies as work experience, work related to human subject research, paid contractual agreement – employer/employee, can be verified by acrp through employer, what is excluded from work experience, any work that is part of a degree track or education program, any experience older than ten years, internships paid or unpaid.

ACRP may grant one experience waiver amounting to 1,500 hours of work experience to applicants who meet one of the following criteria:

Hold an active acrp certification, have successfully completed a clinical research education program*, what qualifies as a clinical research education program*, must be aligned with the topics found in the corresponding detailed content outline (dco), must have a valid third-party accreditation, must provide applicants with knowledge that is equivalent to 1,500 hours of knowledge earned through employment, *program approval is at the discretion of acrp and will not be reviewed or pre-approved outside of a paid application..

The CCRA ® exam consists of 125 multiple choice questions that must be answered within 180 minutes.

The exam is referenced only to the international conference on harmonization (ich) guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)., the following are the only references for which the ccra ® certification exam content can be supported:, ccra ® exam detailed content outline >, guideline for good clinical practice e6 (r2) >, definitions and standards for expedited reporting (e2a) >, general considerations for clinical trials (e8) >, statistical principles for clinical trials (e9) >, clinical trials in pediatric population (e11) >, the declaration of helsinki (doh) >, the global ccra ®  exam committee uses psychometrically sound practices to develop certified clinical research associate (ccra) examinations that meet the current test specifications as determined by the most recent job task analysis (jta)..

Review the Detailed Content Outline and make sure your experience and work hours are appropriate, as outlined in the Eligibility tab.

We also strongly encourage you to review the entire acrp certification handbook , which provides full details about every facet of acrp certification..

Create a free ACRP account so you can begin the application process. Follow the on-screen prompts to enter any requested information and documentation.

If you already have an acrp account, please proceed to step three., create account >.

You’re almost there! Please note, applications selected for audit will undergo a formal review by ACRP’s subject matter experts. In most instances, you will receive a status update about your application within 10 business days.

In accordance with the americans with disabilities act, acrp will provide reasonable accommodations for candidates with disabilities. please complete this special accommodations form for submission with your application before proceeding., acrp’s testing partner psi offers in-person testing, as well as on-demand remote testing available 24 hours a day, every day, during the testing windows., watch these videos to learn what to expect from each option before scheduling your exam..

Find Test Centers Near You >

Schedule your in-person exam >.

Schedule Your Remote Exam >

Check system requirements >.

The best way to prepare for the CCRA ® exam is to fully understand the scope of the exam content and its references.

Please be sure to thoroughly review the following:, acrp certification handbook >, remember: the exam is referenced only to the international conference on harmonization guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)..

We also recommend leaning on your community! Thousands of ACRP Certified members have been in your shoes. They are active community members and always willing to share tips and advice for ACRP exam prep.

Visit the acrp community >.

ACRP offers a variety of training and continuing education programs focused on the key ICH guidelines covered in the CCRA ® exam.

Learn more >.

Exam results are shared immediately at the conclusion of your exam, but PSI will send you an email with your full score report within 24 hours.

Your acrp account will reflect your results within 24 hours..

Congratulations! You just passed a major milestone on your professional journey and are now a member of the elite club of ACRP Certified clinical research professionals.

Keep an eye on your email because you will soon receive information from our digital badging partner credly about claiming your digital badge and how you can use it to tout your accomplishment. also learn how to use your new credential by reviewing the  certification mark policy ., you have 2 years to keep your certification in good standing by continuing your professional development, and we’ll be right there with you every step of the way. in the meantime, we highly recommend you review all the details about maintenance of certification . don’t leave it to the last minute.

Don’t worry. It happens to the best of us. Give it another try!

Refer to your acrp certification examination results email or the acrp certification handbook for guidance on the next steps in your certification journey., upcoming testing dates, spring 2024 testing february 15 – may 15, 2024, fall 2024 testing july 15 – october 15, 2024, 2024  registration dates and fees, early bird registration acrp members – $435 nonmembers – $485 spring 2024:  october 15 – december 31, 2023 fall 2024:  may 15 – july 15, regular registration acrp members – $460 nonmembers – $600 spring 2024:  january 1 – april 30 fall 2024:  july 16 – september 30, join acrp & save, joining acrp helps you save money. more importantly, acrp is where you will find the very best of what you need to design a career path that’s uniquely your own. connections through an engaged community. growth through gold-standard training. and elevation through rigorous certification., explore membership >, exam preparation, congratulations on your decision to earn the most recognized and respected endorsement of clinical research competency — acrp certification. as you start this important journey in your career, we’re here to support you every step of the way..

Clinical Research Coordinator Associate

🔍 school of medicine, stanford, california, united states.

The Division of Cardiovascular Medicine, within Stanford University Department of Medicine, is a dynamic and innovative center dedicated to excellence in research, medical education, and clinical care. Our Division is driven by over 90 faculty members and a cadre of staff who are the pillar of strength in the Division's ongoing efforts into the prevention and treatment of cardiovascular disease.

We are seeking a Clinical Research Coordinator Associate (CRCA) who is passionate about clinical research and wants to deliver results. The CRCA will have the opportunity to work with a robust clinical research team, hand in hand with the Principal Investigators, Clinical Research Manager and other associates in support of the Interventional Affinity Group and the Structural Heart Research Program.

The successful applicant will collaborate with external vendors, and enjoy working in a dynamic work environment. Exceptional diplomacy, interpersonal and communication skills are essential, as is a high degree of integrity. Attention to detail and the ability to manage multiple responsibilities simultaneously are also critical attributes.

If you are interested in supporting translational medicine and contributing to Stanford Medicine’s mission, we invite you to join our team.

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies.  Coordinate studies from start-up through close-out.
• Determine eligibility of and gather consent from study participants according to protocol.  Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects.  Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.

DESIRED QUALIFICATIONS:

• Relevant graduate degree and 3 years of experience in clinical research preferred.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional.
• Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.
• Proven ability to work independently and take ownership of a project.
• Proven ability to work collaboratively and cooperatively in a team environment.
• Ability to work effectively in a fast-paced environment with multiple projects and timelines.
• Detail oriented with excellent organizational skills.
• Excellent communication skills.
• Society of Clinical Research Associates or Association of Clinical.
• Research Professionals certification is preferred.
• Fluency in Spanish is a plus.
• Clinical research project management experience.

EDUCATION & EXPERIENCE (REQUIRED):

• Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.  

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.
• Proficiency with Microsoft Office.

CERTIFICATIONS & LICENSES:

• Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG.  

PHYSICAL REQUIREMENTS:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

  WORKING CONDITIONS:

• Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
• May require extended or unusual work hours based on research requirements and business needs.
• Occasional evening and weekend hours.  

WORKING STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide, http://adminguide.stanford.edu/ .  

The expected pay range for this position is $31.73 - $36.54 hourly. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Why Stanford is for You Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:

• Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
• A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
• A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
• Discovery and fun. Stroll through historic sculptures, trails, and museums.
• Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at [email protected]. For all other inquiries, please submit a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

• Schedule: Full-time
• Job Code: 1013
• Employee Status: Regular
• Requisition ID: 104418
• Work Arrangement : On Site

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Working together, we can reimagine medicine to improve and extend people’s lives.

Study Start Up Senior Lead

About the role, major accountabilities:.

• Responsible for all Study Start-Up (SSU) activities for medium to highly complex high priority studies.
• Full responsibility to independently deliver SSU insights to the development of the trial Operational Execution Plan (OEP) and aligns the SSU plan and strategy accordingly as reflected in SSU systems, milestones and dashboards with Study Leader /Clinical Trial Team (CTT).
• Configures and ensures proper trial-specific set-up of SSU systems (e.g., Expected Document Lists, eTMF, milestones, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS (Clinical Trial Management System), enrollment plan, vendor management tool, site contracting and budgeting tool, ICF template tool, etc.)
• Autonomously strategizes global SSU planning and leads SSU Team (CTT sub-team) from kick-off through completion of SSU (all countries and 95% sites enrolling or as defined per trial

​Leads Global SSU Activation:

• Responsible for global trial level document readiness (including vendor and IMP (Investigational Medicinal Product) and collection into eTMF as necessary for country health authority and Ethics Committee submission and site activation
• Global accountability of timelines, accuracy, and quality of global TMF (Trial Master File) documents in study start-up to ensure TMF inspection readiness

Accountable for country SSU:

• Coaches the country Study Start-up Managers to drive timely start-up activities from country allocation to “Ready to Enroll” within assigned medium to complex trials
• Provides oversight and support to country Study Start-up Managers as needed to ensure that study start-up activities are conducted and completed to plan, including set-up and usage of tools/systems, timely delivery of SSU deliverables (e.g. IRB/IEC submission packages, Informed Consent review, local submission package for submission to IRB/IEC, CTA (Clinical Trial Application) Hub (Europe: acc. to new EU-CTR) as well as Health Authorities and adherence to process standards.
• Guides the VPM as needed to ensure global vendor activation and site readiness in collaboration with to meet site activation timelines/plan.
• Ensure global deliverables to enable site initiation readiness is in place for initial drug release

Experience/Professional requirements:

• A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management, is preferable
• Minimum 6 years' experience in project management, in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
• Minimum 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization
• Fluent English, spoken and written

Leadership Capabilities

• Proven ability and strong experience in leading multidisciplinary teams in a complex matrix environment (including remote or virtual team environments)
• High learning agility championing new technology platforms
• Strong problem solving, negotiation, deadline driven and conflict resolution skills

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. how can we achieve this with our people. it is our associates that drive us each day to reach our ambitions. be a part of this mission and join us learn more here: https://www.novartis.com/about/strategy/people-and-culture  , you’ll receive: you can find everything you need to know about our benefits and rewards in the novartis life handbook. https://www.novartis.com/careers/benefits-rewards, commitment to diversity and inclusion:, novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve., join our novartis network:, if this role is not suitable to your experience or career goals but you wish to stay connected to hear more about novartis and our career opportunities, join the novartis network here: https://talentnetwork.novartis.com/network.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.