At a Glance
- Tasks: Conduct site monitoring visits and ensure compliance with clinical research regulations.
- Company: Join IQVIA, a leader in clinical research and healthcare innovation.
- Benefits: Flexible working, career development, well-being support, and mentorship opportunities.
- Other info: Recognised as a top workplace with excellent growth potential.
- Why this job: Make a real impact on healthcare while advancing your career in a supportive environment.
- Qualifications: 12 months of independent monitoring experience and a degree in a scientific discipline.
The predicted salary is between 30000 - 40000 £ per year.
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.
Why IQVIA?
- Career development opportunities to grow as we grow
- AI‑powered career advancement through our internal talent marketplace, Career Connections
- Mentorship opportunities across the organisation via Employee Resource Groups
- Flexible working to assist work–life balance and professional success
- Well‑being support covering your physical, mental, and financial health
- Awards 2026 "Glassdoor Best Place to Work in the UK" #1 in category - 2026 Fortune® World’s Most Admired Companies™ list (for the FIFTH consecutive year!)
- Brandon Hall Excellence Award for Learning & Development
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 12 months 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.
Apply today and forge a career with greater purpose, make an impact, and never stop learning!
Clinical Monitoring Associate in Portishead employer: IQVIA
At IQVIA, we are dedicated to fostering a supportive and innovative work environment in South West England, where our Clinical Monitoring Associates can thrive. With a strong emphasis on career development through mentorship and AI-powered advancement opportunities, we prioritise your well-being with flexible working arrangements and comprehensive health support. Recognised as one of the 'Best Places to Work in the UK' by Glassdoor, we offer a unique chance to make a meaningful impact in the healthcare sector while continuously learning and growing.
