CRA 1, IQVIA Biotech

IQVIA • Durham, CA

13d

About The Position

IQVIA Biotech is now hiring for CRA 1 with a minimum of 6 months of on-site monitoring. Must have experience monitoring in oncology solid tumor. IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster. 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. In this position, you will ensure that assigned study sites conduct trials in compliance with the protocol, applicable regulations, Good Clinical Practice (GCP), and ICH guidelines. This role is essential in protecting patient safety, ensuring high‑quality clinical data, and maintaining study integrity. Key Responsibilities As a CRA I, you will 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. You will verify that study activities are performed according to regulatory requirements and sponsor expectations, escalating quality concerns as necessary. During these visits, you will 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). A central part of this role involves building and maintaining strong communication with investigative sites. You will provide protocol training, set expectations, address site‑level challenges, and support recruitment planning to help sites meet enrollment targets. You will also 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. Accurate and timely documentation is critical. The CRA I prepare detailed monitoring visit reports, follow‑up letters, and all required study documentation to ensure audit readiness and transparent oversight. The ability to manage multiple tasks, prioritize effectively, and work independently while maintaining productive team relationships is essential for success.

Requirements

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees