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IQVIA UK cFSP team is growing and seeking experienced Clinical Research Associates in South West England. The role involves on-site monitoring across the lifecycle of interventional studies, ensuring GCP/ICH compliance, trainee protocol delivery, and strong site collaboration.
Required are at least 2 years of independent on-site monitoring, a degree in a scientific field, and confidence with AI tools. UK right to work is required; visa sponsorship is not available.
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
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. May support start-up phase
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
Collaborate and liaise with study team members for project execution support as appropriate
Requires at least 2 years independent on-site monitoring experience of interventional studies
Experience across start-up, enrolment, maintenance, close-out
Digital literacy, including confidence using AI tools in a professional setting
Degree in scientific discipline / health care or equivalent industry experience
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Ability to establish and maintain effective working relationships with coworkers and clients
Full UK right to work required, this position is not eligible for visa sponsorship
Join IQVIA on our mission to accelerate innovation for a healthier world!
IQVIA UK's cFSP (sponsor-dedicated) team is growing and seeking experienced Clinical Research Associates in South West England.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.