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Experienced Clinical Research Associate

iqvia · Reading

New
Mid 🇬🇧 English
GCP Trial Master File

Job description

About the role

IQVIA UK's cFSP (sponsor-dedicated) team is growing and is looking for experienced Clinical Research Associates. The role covers site monitoring of interventional studies, working with sites to track recruitment and ensure study quality and regulatory compliance.

Key responsibilities

  • Perform site monitoring visits (selection, initiation, monitoring and close-out) according to the contracted scope of work and regulatory requirements such as GCP and ICH guidelines.
  • Work with sites to adapt, drive and track the subject recruitment plan so it matches project needs.
  • Deliver protocol and study training to assigned sites and keep regular contact to manage ongoing expectations and issues.
  • Evaluate the quality and integrity of site practices, escalate quality issues as appropriate and track regulatory submissions, approvals, recruitment, CRF completion and data queries.
  • Support the start-up phase where required, and ensure site documents are available for the Trial Master File and the Investigator's Site File is kept in line with GCP and local regulations.
  • Create and maintain documentation on site management and monitoring visits, including visit reports, follow-up letters and other study documents.
  • Liaise with study team members to support project execution.

Required profile

  • At least 2 years of on-site monitoring experience of interventional studies.
  • Degree in a scientific discipline or health care, or equivalent industry experience.
  • Ability to build and maintain effective working relationships with colleagues and clients.
  • Full UK right to work; visa sponsorship is not available.

Required skills

  • Good knowledge of, and ability to apply, GCP and ICH regulatory requirements.
  • Site monitoring and study documentation.

What we offer

  • Career development opportunities as the company grows.
  • Flexible working to support work-life balance.
  • Well-being support covering physical, mental and financial health.
  • Awards including Glassdoor Best Place to Work in the UK 2026 and a place on the Fortune World's Most Admired Companies list.

Questions fréquentes

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Source : ats:workday

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Published 2 hours ago

Expires 1 month from now

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iqvia

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