Clinical Research Associate (CRA / Sr CRA)

About the role

Thermo Fisher Scientific is seeking a Clinical Research Associate (CRA / Sr CRA) to join its Clinical Research team. You will monitor and manage clinical trial sites, ensuring compliance with protocols, ICH‑GCP guidelines, 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 process 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 other study documentation within timelines.
• Communicate effectively with sites, sponsors and internal teams.
• Support site feasibility, investigator engagement and regulatory inspections.
• Track study progress in clinical trial management systems (CTMS) and contribute to process improvements.

Required profile

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

Required skills

• Knowledge of ICH‑GCP guidelines.
• Experience with Clinical Trial Management Systems (CTMS).
• Proficiency in risk‑based monitoring methodologies.