At a Glance
- Tasks: Monitor clinical sites and ensure compliance with research protocols and 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 employer with excellent growth opportunities.
- Why this job: Make a real impact on healthcare while advancing your career in a supportive environment.
- Qualifications: 12 months of monitoring experience and a degree in a scientific discipline.
The predicted salary is between 35000 - 45000 £ 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 Research Associate II, South West England in Portishead employer: IQVIA
At IQVIA, we are dedicated to fostering a supportive and innovative work environment that prioritises your professional growth and well-being. As a Clinical Research Associate II in South West England, you will benefit from flexible working arrangements, comprehensive well-being support, and access to mentorship opportunities, all while contributing to our mission of advancing healthcare solutions. Join us and be part of a team recognised as one of the 'Best Places to Work' in the UK, where your contributions truly make a difference.
We think you need these skills to ace Clinical Research Associate II, South West England in Portishead
Site Monitoring
Good Clinical Practice (GCP)
International Conference on Harmonization (ICH) guidelines
Subject Recruitment Planning
Regulatory Submissions and Approvals
Case Report Form (CRF) Management
Data Query Generation and Resolution
