Clinical Research Associate, IQVIA Biotech
Job Overview
We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials.
Key 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.
- Depending on the project, you may also 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).
- Requires 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.
About the Role
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.
Pay
The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. 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).
Schedule
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.