Overview
Join IQVIA’s sponsor-dedicated cFSP team as a Clinical Research Associate in the South West. You will support site monitoring and regulatory compliance to ensure study integrity and patient safety. You will collaborate with sites and the study team to drive recruitment, data quality, and study deliverables. This role offers growth through mentorship, flexible working, and a mission to accelerate innovation for a healthier world. You will work in a global, research-driven environment that values learning and integrity.
Pay / Benefits
- Flexible working
- Well-being support
- Mentorship opportunities
- Career development opportunities
- Internal talent marketplace Career Connections
- Recognition and awards programs
Responsibilities
- Perform site monitoring visits in line with GCP/ICH and contract scope
- Support subject recruitment plans aligned with project needs
- Train sites on protocol and study procedures; maintain communication with sites
- Assess site practices for protocol adherence and regulatory compliance; escalate issues
- Track regulatory submissions, enrollment, CRF completion, data queries; support start-up
- Maintain TMF and ISF documentation per regulatory requirements
- Document site management activities and generate visit reports and letters
- Collaborate with study team to support project execution
Key requirements
- At least 12 months of independent on-site monitoring experience in interventional studies
- Experience across start-up, enrolment, maintenance, close-out
- Digital literacy with confidence using AI tools in a professional setting
- Degree in scientific discipline / health care or equivalent experience
- Strong knowledge of GCP and ICH guidelines
- Ability to establish and maintain effective working relationships
- Full UK right to work; visa sponsorship not available
- excellent communication
- relationship-building
- collaboration
- GCP
- ICH guidelines
- TMF/ISF maintenance
…
