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Clinical Research Associate (CRA)

As a Clinical Research Associate (CRA) within Parexel's Global Monitoring Operations Group, we support you with leading-edge technology, the highest caliber team members, and managers who know your strengths. If you're looking for flexibility and work-life balance, we're here to listen and help you move forward with your individual career path.

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• Category:CRA

【2025年新卒採用】臨床開発モニター/CRA

Bilingual clinical research associate (cra ii/senior) - french/english, fsp clinical research associate / fsp 臨床開発モニター（東京・大阪）, clinical research associate ii, clinical research associate ii - south africa - fsp, clinical research associate - fsp, clinical research associate ii - multisponsor, clinical research associate ii/cra ii, clinical research associate i - czech republic - fsp, senior clinical research associate- fsp, senior cra & cra ii - fsp ( istanbul or ankara) single sponsor, senior clinical research associate - turkey - fsp, clinical research associate (cra) - multisponsor, filter results.

• Administrative (12)
• Biostatistics (6)
• Biotech (8)
• Clinical Logistics (4)
• Clinical Operations Leader (4)
• Clinical Trials (77)
• Data Management (5)
• Finance (6)
• Functional Service Provider (54)
• Human Resources (4)
• Medical Communication (2)
• Medical Sciences (17)
• Medical Writing (2)
• Project Leadership (18)
• Quality Management (8)
• Regulatory / Consulting (27)
• Statistical Programming (8)
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• South Korea (1)
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• Capital Region (1)
• Île-de-France Region (1)
• Istanbul (1)
• Kowloon City (1)
• Ōsaka (2)
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Learn about Our Culture

Neuroscience Careers

Neuroscience diseases affect the very core of one’s being and experience. We work diligently to lighten the burden for patients and families alike. Explore opportunities to join our team.

Careers in Inflammation & Immunology

Each day, we’re working toward building a deeper connection and understanding with those who count on us – the patients.

Cell and Gene Careers

Cell and gene therapies (CAGT) have rapidly emerged as among the fastest-growing spaces in all of biopharma R&D, and Parexel was an early entrant into this space.

Our work culture

Learn about our culture, perks, learning opportunities, and our corporate responsibility approach.

Careers in Oncology

Our dedicated people, innovative approaches, and culture of caring all work together to ease the journey for patients and investigators.

Careers in Rare Diseases

In rare disease, every single patient is precious. Discover where your skills can create a life-changing achievement for every person involved.

Emerging Talent Programs

Begin your career journey at Parexel with our emerging talent programs or our internships, placements and apprenticeships. Advance science by keeping the patients at the heart.

How to Apply

It’s all about finding the right fit, for you and for us. Our recruiters work with you and our hiring managers to bring together a team and culture where everyone can grow and be successful.

Meet Rebecca, a Project Leader highlighting empathy

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Roles within Project Leadership

Join Parexel's Global Project Leadership group, comprising 500+ employees in 35 countries and drive success for Enterprise and Biotech clients. With our dynamic team structure, management systems, training, and support, you'll have the tools and expertise to excel as a Project Leader and contribute to life-changing therapies.

Follow us on Social Media

Parexel is present on several social media channels where we post our latest updates. Follow, interact, and rate us!

Roles within Medical Writing

Make a difference with a role in Medical Writing

Flexible Work Arrangement

In-office, home-based or a mix? What’s your preference? We value the work-life balance of our employees, and as such Parexel is offering maximum flexibility to our employees wherever possible.

Roles within Clinical Operations

Are you passionate about making a difference in the fight against cancer and beyond? At Parexel's Global Clinical Operations, we are dedicated to putting patients at the heart of every clinical trial. With a global footprint and 5000 Clinical Operations team members worldwide, we are impacting clinical research.

A day in a life of a Project Leader

Christine and Ewa share what a Project Leader does, why to become a Project Leader, and what mindset is needed. Explore how a Project Leader resembles a cheerleader or a coxswain of a rowing boat!

Meet Lola: Senior Clinical Research Associate

Lola shares about her position as a Senior Clinical Research Associate (Sr. CRA), what skills are needed for her role, and what she enjoys outside of work!

Meet Stephanie: Director, Regulatory Affairs (USA)

Stephanie is leading a team and providing regulatory consulting for a variety of medical device clients. In this interview, Stephanie talks about her role, the projects she works on, and her passion for helping clients address unmet medical needs.

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Within our outsourcing model, you are deployed as an experienced colleague for our customers, benefiting from exposure to both the clinical research organization (CRO) and sponsor experience.

Roles within Data Operations

Impact patients with a role in Biostatistics, Statistical Programming and Data Management.

Meet David: Executive Director, Business Development & Co-Lead Disability Steering Committee

David shares what is involved to get the right research solution to clients and patients. As a differently-abled person, he talks about his experience and achievements whilst working at Parexel.

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Amrita tells us about how Parexel has helped her grow within her career with working flexibility and opportunities to learn.

Meet Janice: Principal Statistical Programmer FSP

Janice You shares why she choose Parexel FSP. Find out which skills are needed in her role, what she enjoys the most, as well as what challenges her.

Meet Neha: Senior Biostatistician

Neha describes her role as a Senior Biostatistician and why she chose Parexel.

Meet Gabriela: Project Specialist II

Read how Gabriela, as a Project Specialist, is contributing to the achievement and compliance of study deliverables to benefit our common goal of bringing a new therapy to patients.

Meet Rahul: Senior Health Economics Associate

Rahul describes his role as a Senior Health Economics Associate in the Health Economics and Outcomes Research team

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Joanna provides insights about her role as a Senior Medical Writer. She describes what excites her about the role and what it is like working with highly educated, motivated, and professional colleagues.

Meet Mary: Principal Medical Writer

Mary provides insights about her role as a Principal Medical Writer. She shares what it is like working with her fellow colleagues, how Parexel has supported her career development, and what excites her most about the work she does.

Meet Chanakarn: Clinical Research Associate II

Charnakarn talks about what it is like to be a CRA, and the support she has been given to achieve her career goals.

Rebuilding Careers: How Ashwini rediscovered her confidence at Parexel

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Returning with Passion: What Marlayna experienced coming back to Parexel

After a brief departure, Marlayna joined as a Senior Clinical Research Associate and transitioned later into being a field coach and mentor for new CRAs. When returning Marlayna discovered a company more committed than ever to employee well-being and belonging.

Meet Sheryl: Principal Consultant, Regulatory & Access

Sheryl, Principal Consultant, talks about why she joined Parexel and how she keeps the patient first.

Meet Kanika: Manager in Project Manager

Kanika describes her role within finance operations and why she chose to join Parexel

Meet Cheri & Tarryn: Project Specialist II

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Meet Jamie: Diversity & Inclusion

Jamie offers her perspective on Parexel’s inclusivity to LGBTQ+ colleagues, how she feels about being "out" at work, and more.

Meet Kirill: Executive Director, FSP Biometrics

Kirill describes what excites him about his role and how he tries to challenge and encourage his staff.

Meet Santino: Clinical Operations Leader

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Meet Siddhika: Clinical Data Analyst III

Meet Siddhika, Clinical Data Analyst III as she explains why she decided to apply to Parexel after a six year career break

Meet Jitender: Director, Health Economics

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Meet Jagan: Director, India Assistant Compliance Officer

Jagan describes his role as a Director within the compliance team based in India

Catalyst Award Winner 2022

Catalyst is advancing workplaces that work for Women - Parexel was recognized for "Leveraging Gender Partnership to Advance Women in Leadership."

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Meet Simona: Principal Consultant, Regulatory & Access

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UK Career Webinar — Accelerate your career in Clinical Project Leadership

View this career webinar to hear from our Clinical Project Leadership team in the UK about their opportunities for growth and the team's culture at Parexel.

Meet Joy: Senior Director, Statistical Programming

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Meet Celine: Director for Integrated Solutions Strategy

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Meet Jens Zurrahn, Senior Director for Medical Writing Services, as he discusses his role at Parexel.

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View this career seminar to hear from our Clinical Operations colleagues and Clinical Research Associates about the role of a CRA and working in Clinical Operations at Parexel.

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View this webinar to hear from our Clinical Operations colleagues and Clinical Research Associates about the role of a CRA working in Clinical Operations at Parexel

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Urvashi tells us why she chose Parexel and what she enjoys being a Medical Writer I

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Penny, Senior Clinical Research Associate, shares the reason why she kept coming back to Parexel, the responsibilities of her role and how she keeps the patient at the heart of everything she does.

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Parexel employee base is 70 % female, and we are proud to say 60 % of managers+ and 46 % of VP-level+ are female. Yet we are committed to improving these numbers with several leadership programs for female and male colleagues!

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Location: Durham, NC (USA)

Parexel establishes Headquarter Two in Durham, North Carolina.

Location: Argentina

Work where you will find flexible working options, a supportive atmosphere, constant learning, and more.

Location: India

Join one of our 5 locations in India. Parexel India employs ~5770 employees, which represents 25% of our global population. We offer a supportive and fun work culture, flexibility, career growth, and learning opportunities.

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At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture.

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Find out more about how we live our DE&I pillars: Patients, People, and Suppliers.

Join our APEX Program and become a CRA

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From Clinical Operations Leader to Director: Catia's path at Parexel

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Parexel's Newsroom

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Parexel Military Talent Community

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Watch Replay: CRAs of the Future

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Meet Adrian, a Site Care Partner navigating the complex landscape of clinical trials.

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Meet Rachel Smith: Global Head of Rare Disease, CoE

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Meet Jessica, an Associate Project Director guiding trials through the complex regulatory landscape

Jessica works as an Associate Project Director within our Regulatory and Access Global Project Leadership team. Learn more about Jessica's experience and how she contributes to the success of clinical trials.

Meet Anthony, a Senior Principal Medical Writer contributing to lifesaving treatments and therapies

Anthony's has worked as a Medical Writer for more than 17 years. In his current role as Senior Principal Medical Writer, discover how Anthony's work contributes to therapy development and clinical trials.

Meet Stuti, a Senior Regulatory Affairs Consultant guiding clinical trials through development and approval

Working as a Senior Regulatory Affairs Consultant, Stuti is helping to lead clients through the development and approval of products to get treatments to patients faster.

Why Clinical Operations Leaders work at Parexel

Listen to Elizabeth Edwards, SVP Clinical Operations at Parexel, as she delves into why she works With Heart™, the impact of Clinical Operations Leaders, how Parexel supports their success, and what makes Parexel's culture unique.

Clinical Research Associate 1

Coordination of clinical research studies. performance of regulatory tasks including irb and sponsor/cro regulatory correspondence..

• Science and Medical Research
• Opening on: Apr 22 2024
• Research Foundation
• Clinical Research Associate I, E99

Job Summary:

Coordination of clinical research studies. Performance of regulatory tasks including IRB and sponsor/CRO regulatory correspondence. Communication with IRBs, sponsors, and protocol-related Upstate Departments. Pre-screen, Screen, and enroll research participants in outpatient and inpatient clinical trials. Process and ship lab samples. Schedule and conduct follow up research appointments for clinical trial participants. Data collection and entry into paper and electronic databases. Maintenance of clinical research supply inventory. Processing clinical trial billing and payments. Administration of study questionnaires and assessments. Occasional travel.

Minimum Qualifications:

Bachelor's degree and 2-year's related experience or equivalent combination of education and experience.

Preferred Qualifications:

Prior experience with clinical research protocols and/or experience with coordinating clinical trials. ACRP and/or SOCRA certification.

Mon- Fri 8-4:30 with occasional after hours

Message to Applicants:

Salary Range-$58,000-$60,000

Recruitment Office: Human Resources

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or disability or other protected classes under State and Federal law.

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We are taking clinical research to the next level. Leverage data, in-house technologies and analytics to enable evidenced-based solutions that will help reimagine clinical development and improve patient outcomes.

Joining IQVIA means unlocking access to supportive leadership, a wide variety of career opportunities and technology-enabled resources that make doing your job more efficient. Here, you'll gain a sense of pride that comes with being part of something bigger than you ever imagined.

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Our clinical research associates play a vital role in driving the evolution of clinical development. They bring passion, ambition and a deep level of expertise that’s used to help solve complex clinical issues while ensuring adherence to regulations and sponsor requirements.

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From strategy development to trial execution to regulatory management, embark on a fulfilling career on IQVIA’s Clinical Operations team. Pair your drug development process expertise and our in-house technologies to deliver best-in-class customer and site experiences, and more notably, make a meaningful impact on improving patient lives.

Clinical Project Management & Leadership Careers

Play a pivotal role in driving clinical trial delivery through right first-time behavior and risk-based project management with a career in Clinical Project Management / Leadership at IQVIA. With a steadfast focus on quality, meticulous financial control and strong communication skills, you’ll serve as a trusted liaison between IQVIA and our customers. Spearhead medical breakthroughs that will leave a lasting impact on patients around the globe.

Clinical Data Management Careers

Transform clinical trial efficiency and deliver medical breakthroughs faster. Clinical Data Management oversees the acquisition, validation and analysis of complex clinical trial data, ensuring its accuracy and compliance with regulatory guidelines. Put your passions to work with a career contributing to life-changing research that positively impacts patient outcomes and shapes the future of healthcare.

Statistical Services Careers

A Statistical Services career means harnessing the power of diverse datasets and strategic methodologies to unlock new possibilities for clinical trials. Working cross-functionally with teams around the world, you’ll develop innovative statistical strategies and analytical solutions to support evidence-based decision-making and help customers navigate the complexities of drug development and regulatory submissions.

At IQVIA, I always value our ability to positively impact patient lives, the supportive leadership and the abundance of growth opportunities available. I know my goal of becoming a Regional Head or Alliance Lead is achievable here.

Christy Willetts

Associate Director, Clinical Operations

Not only does IQVIA provide us excellent with standard training, but we have resources to help us gain knowledge and soft skills as well as supportive colleagues to help problem solve and navigate the changing day-to-day responsibilities of a CRA. I also love our passion for continuous growth and the ample development opportunities that will enable me a successful future here.

Senior Clinical Research Associate

IQVIA invests in me, awakens my talent, and helps me develop skills for new opportunities. As a Project Leader, I’m building teams and processes to support all stages of the project lifecycle. What makes it all worth it? Everything I do contributes to the improvement of patients’ health and well-being.

Nadezhda Simeonova

Senior Clinical Project Manager

When I started my career at IQVIA, I was impressed by the in-house technology. Ten years later, I’m even more impressed. But for me, it’s the people. I’ve had the opportunity to mentor project leaders as well as be a mentee. Growing with my colleagues makes me feel closer and that we’re all empowering each other to be our best.

Julie Lightfoot

Clinical Project Management Director

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Clinical Research Coordinator Associate

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

Clinical Research Coordinator for Cognitive Aging, Dementia, and Parkinson’s disease 

Do you want to help Stanford University develop world-leading research to better diagnose and treat people suffering from Parkinson’s disease, Dementia with Lewy Bodies and Alzheimer’s disease?

If you…

• Enjoy working directly with patients and their families.
• Are exceptionally organized and can balance multiple projects at one time.
• Love learning new skills, such as how to administer neurological and memory tests.
• Are a proven quick learner who doesn’t need handholding to get started.

Then we offer…

• The opportunity to contribute to understanding Alzheimer’s disease and Parkinson’s disease.
• Challenging but positive environment where you will always learn new things.
• Teamwork and camaraderie.
• Competitive full-time salary.
• Excellent Stanford benefits.

The Poston Lab recruits and follows older normal adults; older adults with mild cognitive impairment; and patients with Parkinson’s disease, Dementia with Lewy Bodies, Alzheimer’s disease, and related disorders. These studies collect information on memory and other mental abilities, which we link with brain imaging, biochemical and genetic markers, and autopsy results. Most research participants will have Parkinson’s disease, Dementia with Lewy Bodies, Alzheimer's disease, or another neurodegenerative disorder; some participants will be not have any impairment.    

The Poston Lab seeks a full-time Clinical Research Coordinator Associate. The desired candidate is self-motivated, detail-oriented, relatively independent, patient, punctual, and conscientious, with excellent interpersonal skills and excellent communication skills in English. Preference will be given to qualified candidates, who are also native/fluent in Spanish (written and verbal). Under the supervision of Dr. Poston and other investigators at the Stanford Alzheimer’s Disease Research Center (ADRC), main duties include in-person and telephone recruitment of research participants; obtaining informed consent; scheduling and coordination of research participant visits; maintaining longitudinal contact with participants by phone, email and other means; data collection (including psychometric data), scoring, and data entry.  Training will be provided to administer research questionnaires and administer psychometric tests.

We like working with other smart, motivated, fun people looking to better the lives of our patients through scientific discovery. In addition to submitting your on-line resume, please include a cover letter describing your prior clinical research experience and the top five attributes or experiences that make this the right job for you. For more information about our lab and research, please see http://neurology.stanford.edu/labs/postonlab/ .

Duties include*:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup 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. 

*- Other duties may also be assigned.

DESIRED QUALIFICATIONS:

• Excellent verbal and written communication skills in English required.
• Excellent verbal and written communication skills in Spanish desired.
• Prior experience with patients or research subjects is desired. Preference given to applicants with previous experience, particularly clinical research experience, with older adults who may have neurological impairment (e.g., Parkinson’s disease) or cognitive impairment (e.g., Alzheimer’s disease). 
• Ability to communicate clearly and empathetically with research participants and their families.
• Strong interpersonal skills, including the ability to work easily with research participants and research team members.
• Strong general computer skills and ability to quickly learn and master computer programs.
• Strong analytical skills and experience with computer spreadsheets and database software.
• Proficiency with Microsoft Office and Excel.
• Ability to work under deadlines with general guidance.

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.
• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 

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.

*- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS: 

Occasional evening and weekend hours.

WORK 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 to $36.54 per hour.

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 ( https://cardinalatwork.stanford.edu/benefits-rewards ) 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.

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 by submitting 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.

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.

• Schedule: Full-time
• Job Code: 1013
• Employee Status: Regular
• Requisition ID: 102979
• Work Arrangement : On Site

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Clinical Research Interviewer/Research Associate

Posted: monday, april 22nd, 2024, description.

Job Description

An NIH-funded Clinical Research Interviewer is being sought for the labs of Dr. Pearl Chiu and Dr. Brooks Casas at the Fralin Biomedical Research Institute at Virginia Tech Carilion (http://research.vtc.vt.edu) in Roanoke, Virginia. Projects in the labs are highly interdisciplinary and combine methods from experimental and clinical psychology, neuroscience, and behavioral economics with functional neuroimaging and in vivo electrochemistry to investigate decision-making in healthy and clinical populations (focusing on adults with mood, anxiety, trauma, or substance-use disorders, and at-risk youth). This is an excellent opportunity for a detail-oriented person who enjoys interacting with others, being a key part of a diverse and active scientific environment and working with individuals with varied mental health difficulties. The Clinical Research Interviewer will primarily be responsible for the administration of clinical interviews such as the Structured Clinical Interviews for DSM-5 and the Kiddie Schedule for Affective Disorders and Schizophrenia, as well as various symptom or neuropsychological assessment measures to determine study eligibility. Applicant must have knowledge and experience utilizing the DSM-5, and will be expected to possess subject matter expertise in psychiatric diagnostic assessment across adults and adolescents. The Clinical Research Interviewer will also be expected to implement crisis management procedures, and assist with neuroimaging. Other duties may include participant recruitment/screening and oversight, and general clinical research management and supervision of research assistants.

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Areas Of Work Select Administrative Operations Auxiliary Services Faculty Human Resources Information Technology Keck Medicine of USC

Employment Type Select Faculty Full Time Faculty Part Time Staff Full Time Staff Part Time

Let’s change the world together!

USC is a leading private research university located in Los Angeles – a global center for arts, technology and international business. As one of the city’s largest private employers, responsible for more than $8 billion annually in economic activity in the region, we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills across a variety of academic schools and units. As a USC employee, you will enjoy excellent benefits and perks , and you will be a member of the Trojan Family - the faculty, staff, students and alumni who make USC a great place to work. Think you’ve got what it takes to join us? We invite you to search our open positions and apply!

Lead Clinical Research Associate

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer’s Disease (AD) through innovative clinical trials.

Incumbent will lead and provide guidance to clinical monitors for sponsor and investigator initiated clinical research studies.  Assists in administration of the consent process, and ensures maintained records are accurate, complete, timely, and compliant. Serves as communications liaison for clinical monitoring and study teams, identifying, resolving, and escalating any issues, as appropriate. Develops and administers clinical trial education and training.  Duties will include but are not limited to:

• Develop and maintain study specific clinical monitoring documentation. Review and contribute to clinical monitoring sections of other study documents. Support development and maintenance of departmental and study SOPs and Work Instructions.
• Conduct study specific onboarding and training of team members new to the study. Conduct onsite training visits.
• Represent Clinical Monitoring Team at study specific meetings. Provide study updates on Clinical Monitoring team metrics, site escalations, and other monitoring efforts. Support study start up, maintenance, and close out activities. Participate in interdepartmental meetings to accomplish study milestones. Collaborate with colleagues to address study issues.
• Expert knowledge and awareness of study manuals to serve as main point of contact for issues identified by study CRAs. Review study status reports and prioritize monitoring activities with study CRAs to meet study milestones.
• Review Monitor Visit Reports (MVR) and provide feedback to team. Provide oversight of monitor visit compliance with study plans. Escalate problematic behavior and poor performance to CRA Managers as needed.
• Participate in sponsor, internal, and regulatory audits as needed.
• Participate in eTMF filing efforts as needed.
• Review study data in accordance with Clinical Monitoring Plan. Issue and resolves queries in a timely manner. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance.
• Conduct onsite and remote monitoring visits for assigned clinical sites. Review Investigator Site Files, study data, perform IP accountability, and other monitoring visit activities.  Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Up to 50% travel may be required.
• Act as main point of contact for assigned clinical sites and respond to communication via study inbox ticketing system in a timely manner.
• Experience in AD research is preferred.

Location:  San Diego, CA

The annual base salary range for this position is $110,750.64- $158,554.68. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

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