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Clinical Trials Associate

United Kingdom, Hitchin · Job Posted May 17, 2026
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Job Description

As a Clinical Trials Associate, you will support the successful delivery of clinical studies through effective coordination, documentation management, and administrative support. A core focus of this role will be ownership and maintenance of the TMF, ensuring compliance with regulatory standards and inspection readiness.

Job Responsibility

  • Managing Trial Master File (TMF) activities, including set-up, maintenance, QC checks, and archiving
  • Ensuring TMF completeness, accuracy, and inspection readiness throughout the study lifecycle
  • Supporting clinical trial administration across study start-up, conduct, and close-out activities
  • Preparing and maintaining study documentation, meeting minutes, and tracking logs
  • Assisting with site set-up activities, including preparation and QC of Investigator Site Files (ISFs)
  • Coordinating shipment of essential documents and materials to clinical sites
  • Supporting study visits such as Site Initiation Visits and study close-outs
  • Assisting with invoice tracking, budget monitoring, and site payments
  • Contributing to data management activities including data entry and quality control

Requirements

  • At least 2 years of recent experience working within clinical trials
  • Strong hands-on experience managing or supporting Trial Master Files (TMF)
  • A solid understanding of working in a regulated environment (GCP)
  • Excellent organisational skills and attention to detail
  • Confidence using electronic systems and managing documentation
  • Strong communication skills and the ability to work collaboratively across teams
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