Clinical Research Associate, IQVIA Biotech

IQVIA • Durham, NC

4d • $71,900 - $169,300 • Onsite

About The Position

IQVIA Biotech is seeking a dedicated Clinical Research Associate (CRA) to join their team. This role is crucial for ensuring the successful execution of clinical trials by monitoring and managing clinical sites. The CRA will ensure compliance with study protocols, regulatory requirements, and sponsor expectations, directly contributing to the integrity and quality of clinical research data. IQVIA Biotech is a full-service CRO that serves biotech sponsors, offering agile, therapeutically aligned solutions and trusted partnerships to accelerate the delivery of breakthrough treatments to patients.

Requirements

• Bachelor’s degree in life sciences or health-related field (or equivalent experience).
• At least 1 year of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Ability to travel as required by the project.
• Experience monitoring in oncology solid tumor.

Nice To Haves

• CRA 1 candidates with a minimum of 6 months on-site monitoring experience will also be considered.

Responsibilities

• Conduct all types of site visits—selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (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.
• Support site-level recruitment planning and financial management, including invoice collection and budget tracking, depending on the project.

Benefits

• Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level