CRA 1, IQVIA Biotech

Austin, United States of America | Full time | Field-based | R1534476 Clinical Research Associate I (CRA I) Job Overview The CRA I supports the successful conduct of clinical research studies by performing site monitoring and site management activities. The role ensures that assigned study sites conduct trials in compliance with the protocol, applicable regulations, Good Clinical Practice (GCP), and ICH guidelines, protecting patient safety and maintaining study integrity across oncology solid tumor studies. Key Responsibilities Conduct site selection, initiation, routine monitoring, and close‑out visits to evaluate quality and integrity of site practices. Verify study activities comply with regulatory requirements and sponsor expectations, escalating concerns as necessary. Review essential documents, assess protocol adherence, oversee data entry and query resolution, and maintain the Trial Master File (TMF) and Investigator Site File (ISF). Build and maintain strong communication with investigative sites, provide protocol training, address site‑level challenges, and support recruitment planning to meet enrollment targets. Collaborate closely with internal project teams to ensure cohesive study execution and contribute to site‑level financial processes or start‑up activities as needed. Prepare detailed monitoring visit reports, follow‑up letters, and all required study documentation to ensure audit readiness and transparent oversight. Qualifications Bachelor’s degree required; a scientific or healthcare discipline is preferred. 6 months to 2 years of relevant experience, or an equivalent combination of education, training, or completion of a CRA training program. Basic knowledge of clinical research regulations (GCP/ICH). Ability to travel as required by the project. Experience monitoring oncology solid tumor studies. Compensation The potential base pay range for this role, when annualized, is $71,900.00 - $119,900.00. Incentive plans, bonuses, and other benefits may also be offered. 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. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. #J-18808-Ljbffr