Description
Join IQVIA on its mission to drive healthcare forward as a Clinical Research Associate in the UK.
IQVIA, a recognised leader in clinical research services, is seeking experienced professionals to join its team.
Responsibilities:
- Conduct site monitoring visits, including selection, initiation, monitoring, and close-out visits, adhering to contracted scope of work and regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Collaborate with sites to adapt, drive, and track subject recruitment plans, ensuring alignment with project needs and enhancing predictability
- Provide protocol and related study training to assigned sites, establishing regular communication channels to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices, ensuring compliance with the protocol and applicable regulations, and escalate quality issues as necessary
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
- Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained according to GCP and local regulatory requirements
- Create and maintain documentation regarding site management, monitoring visit findings, and action plans through regular visit reports, follow-up letters, and other required study documentation
- Collaborate with study team members to support project execution
Requirements:
- Minimum 6 months of experience in independent on-site monitoring
- Proven ability to manage multiple clinical trial protocols across diverse investigative sites
- In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Life science degree education or equivalent industry experience
- Flexibility to travel to sites
What We Offer:
- Opportunities for genuine career development within the organisation
- Chance to work on cutting-edge medicines at the forefront of new medicines development
- Access to significant data pools to enhance site selection, recruitment, and performance
Note: This role is not eligible for UK visa sponsorship.