CRA 2, IQVIA Biotech

IQVIA Biotech is now hiring for a CRA 2 with a minimum of 1 year of on‑site monitoring experience in CAR‑T and/or Cell & Gene Therapy. IQVIA Biotech is a full‑service CRO purpose‑built to serve biotech sponsors. Job Overview We are seeking a dedicated Clinical Research Associate (CRA) to manage clinical sites and ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Key Responsibilities Conduct all types of site visits—selection, initiation, monitoring, and close‑out—in alignment with the contracted scope of work, GCP, and ICH guidelines. Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals. Deliver protocol and study‑specific training to site personnel and maintain consistent communication to manage expectations and resolve issues. Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity. Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries. Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. Document site management activities, visit outcomes, and follow‑up actions through detailed reports and correspondence. Work closely with cross‑functional project teams to support study execution and ensure alignment with project goals. Depending on the project, support site‑level recruitment planning and financial management, including invoice collection and budget tracking. Qualifications Bachelor’s degree in life sciences or health‑related field (or equivalent experience). Minimum of 1 year of on‑site monitoring experience. Strong understanding of GCP, ICH guidelines, and regulatory requirements. Ability to travel as required by the project. Equal Opportunity Employer IQVIA is proud to be 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, disability, status as a protected veteran, or any other status protected by applicable law. Compensation and Benefits The potential base pay range for this role, when annualized, is $71,900.00 – $145,300.00. The actual base pay offered may vary based on qualifications, location, and schedule. Incentive plans, bonuses, and other forms of compensation may also be offered, along with a range of health and welfare benefits. Thank you for your interest in growing your career with us. #J-18808-Ljbffr IQVIA LLC