Clinical Research Associate (CRA II) – CAR-T | IQVIA Biotech
Location: Durham, North Carolina
Job ID: R1481904
Type: Full-time | Field-based
Travel: Required
Additional Locations: Available
Overview
IQVIA Biotech is hiring a CRA II with at least 1 year of on-site monitoring experience and proven CAR-T therapy expertise.
We are a full-service CRO designed specifically for biotech sponsors, combining over 25 years of experience with agile, therapeutically aligned solutions to help bring breakthrough treatments to patients faster.
Role Summary
As a Clinical Research Associate (CRA II), you will ensure the integrity, quality, and compliance of clinical trials by monitoring investigative sites and maintaining adherence to study protocols, regulatory standards, and sponsor expectations.
Your work directly contributes to the successful execution and data reliability of cutting-edge CAR-T studies.
Key Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits according to GCP, ICH, and study protocols.
Collaborate with investigative sites to develop and maintain subject recruitment strategies aligned with study timelines.
Provide protocol and study-specific training to site staff; maintain continuous communication to address issues proactively.
Evaluate site performance, data accuracy, and protocol adherence; escalate compliance issues as appropriate.
Track regulatory submissions, enrollment progress, CRF completion, and query resolution.
Maintain complete and compliant Trial Master File (TMF) and Investigator Site File (ISF) documentation.
Document all monitoring activities, visit outcomes, and required follow-ups through detailed written reports.
Partner with cross-functional project teams to align operational progress with overall study goals.
Support site-level recruitment planning, invoicing, and budget tracking where applicable.
Qualifications
Education:
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or other health-related discipline (or equivalent experience).
Experience:
Minimum 1 year of on-site monitoring experience.
Experience in CAR-T or cell therapy studies strongly preferred.
Knowledge & Skills:
Thorough understanding of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
Strong communication, organization, and problem-solving abilities.
Ability to travel as required by project needs.
Compensation
Annual Base Pay Range: $57,500 – $174,400
Actual compensation will vary based on education, experience, skills, and location.
Additional bonuses, incentive plans, or other compensation may apply.
Eligible for a comprehensive range of health and welfare benefits (dependent on role specifics).
About IQVIA Biotech
IQVIA Biotech, part of IQVIA, provides innovative CRO services purpose-built for biotech companies.
We combine therapeutic expertise, operational agility, and data-driven insights to accelerate the development and commercialization of advanced medical treatments — especially in oncology, immunotherapy, and cell therapy.
🔗 Learn more: https://jobs.iqvia.com
Equal Employment Opportunity
IQVIA is proud to be an Equal Opportunity Employer.
All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
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