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Clinical Research Associate (CRA / Sr. CRA)

Thermo Fisher Scientific

🇬🇧 English
CTMS

Job description

About the role

Thermo Fisher Scientific is seeking a Clinical Research Associate (CRA / Sr. CRA) to support its global clinical research programs. The role involves monitoring and managing trial sites to ensure compliance with protocols, ICH‑GCP, and regulatory requirements while safeguarding patient safety and data integrity.

Key responsibilities

  • Conduct on‑site and remote monitoring visits using a risk‑based approach.
  • Review source documents, case report forms (CRFs) and study data for accuracy and completeness.
  • Perform site initiation, routine monitoring, and close‑out activities.
  • Assess investigational product accountability and inventory records.
  • Identify site issues, conduct root‑cause analysis, and support corrective actions.
  • Maintain essential documents in line with ICH‑GCP and regulatory standards.
  • Prepare monitoring reports, follow‑up letters and study documentation within timelines.
  • Communicate effectively with sites, sponsors and internal teams.
  • Track study progress in clinical trial management systems (CTMS) and support audits and inspections.

Required profile

  • Bachelor’s degree in Life Sciences, Nursing or a related healthcare field, or equivalent experience.
  • Valid driver’s license (where applicable) and ability to travel as required.
  • Relevant clinical research or monitoring experience in the pharmaceutical/biotech sector.

Required skills

  • Experience with Clinical Trial Management Systems (CTMS).

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Published 3 months ago

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Thermo Fisher Scientific