At a Glance
- Tasks: Monitor clinical sites and ensure compliance with regulations while supporting study execution.
- Company: Join a leading clinical research organisation dedicated to innovation and excellence.
- Benefits: Enjoy flexible working, well-being support, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on work-life balance and career development.
- Why this job: Make a real difference in healthcare by contributing to groundbreaking clinical studies.
- Qualifications: 6 months of monitoring experience and a degree in a scientific discipline required.
The predicted salary is between 30000 - 40000 £ per year.
IQVIA UK’s cFSP (sponsor‑dedicated) team is growing and seeking experienced Clinical Research Associates in South West England.
Responsibilities
- 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.
Requirements
- Requires at least 6 months independent on‑site monitoring experience of interventional studies.
- Experience across start‑up, enrollment, 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.
Benefits
- Flexible working to assist work‑life balance and professional success.
- Well‑being support covering your physical, mental, and financial health.
Clinical Research Associate, South West England employer: IQVIA LLC
IQVIA UK is an exceptional employer for Clinical Research Associates in South West England, offering a supportive work culture that prioritises flexibility and work-life balance. Employees benefit from comprehensive well-being support, opportunities for professional growth, and the chance to work on impactful clinical studies that contribute to advancements in healthcare.
We think you need these skills to ace Clinical Research Associate, South West England
Site Monitoring
Good Clinical Practice (GCP)
International Conference on Harmonization (ICH) guidelines
Subject Recruitment Planning
Protocol Administration
Regulatory Submissions and Approvals
Data Query Generation and Resolution
