Clinical Trials Coordinator – Hybrid UK

Regeneron UK Limited

Uxbridge

Hybrid

GBP 32,000 - 52,000

Full time

38 hours ago
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Job summary

Regeneron UK Limited is seeking a Clinical Study Associate, Clinical Operations to support multiple trials from our Hybrid Uxbridge office. The role involves ensuring compliance with SOPs, GCP, ICH guidelines, and regulations, plus coordinating study team meetings and essential document workflows.

The ideal candidate has 0-1 year of relevant experience, a life sciences degree, and familiarity with CTMS/eTMF systems to maintain accurate trial data and regulatory submissions.

Qualifications

  • Bachelor's degree preferred in life sciences or related field.
  • 0-1 year of relevant clinical operations experience.
  • Knowledge of GCP, ICH guidelines, and applicable regulations.
  • Experience reviewing study documentation and eTMF.
  • Familiarity with CTMS and clinical reporting tools.

Responsibilities

  • Support multiple clinical trials while ensuring SOPs, GCP, ICH guidelines and regulations.
  • Coordinate study team meetings, agendas, minutes and logistics.
  • Request, collect, review and track site regulatory documents and start-up activities.
  • Maintain, reconcile and quality check essential documents and the eTMF.
  • Support study reporting tools, monitoring visit schedules, investigator materials and study binders.
  • Manage Clinical Disclosure Agreements, consulting agreements and internal review submissions.
  • Maintain data in CTMS and monitor study disclosure requirements.
  • Track study closeout activities, reports and CRA closeout visits.

Skills

GCP knowledge
ICH guidelines
CTMS familiarity
Regulatory documentation
Coordination
Collaboration across teams

Education

Bachelor's degree in life sciences or related field
Associate degree considered

Tools

CTMS
eTMF

Job description

Regeneron UK Limited is seeking a Clinical Study Associate, Clinical Operations to support multiple trials from our Hybrid Uxbridge office. The role involves ensuring compliance with SOPs, GCP, ICH guidelines, and regulations, plus coordinating study team meetings and essential document workflows.

The ideal candidate has 0-1 year of relevant experience, a life sciences degree, and familiarity with CTMS/eTMF systems to maintain accurate trial data and regulatory submissions.

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