CRA 1, IQVIA Biotech

Job Overview

The Clinical Research Associate I (CRA I) plays a key role in supporting the successful conduct of clinical research studies by performing site monitoring and site management activities.

Key Responsibilities

• Conduct various types of monitoring visits—including site selection, initiation, routine monitoring, and close-out visits—to evaluate the quality and integrity of site practices.
• Verify that study activities are performed according to regulatory requirements and sponsor expectations, escalating quality concerns as necessary.
• Review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the Investigator Site File (ISF).
• Build and maintain strong communication with investigative sites. Provide protocol training, set expectations, address site-level challenges, and support recruitment planning to help sites meet enrollment targets.
• Collaborate closely with internal project teams to ensure cohesive study execution and may contribute to site-level financial processes or start-up activities based on study needs.
• 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 – 2 years of relevant experience, with equivalent combinations of education, training, or completion of a CRA training program considered.
• Basic knowledge of clinical research regulations (GCP/ICH).
• Ability to travel as required by the project.

Pay

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 a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).