Clinical Research Associate (CRA / Sr. CRA)

About the role

Thermo Fisher Scientific is seeking a Clinical Research Associate (CRA) or Senior CRA to join its Clinical Research team. You will monitor and manage clinical trial sites worldwide, ensuring compliance with study protocols, ICH‑GCP guidelines, and regulatory requirements while protecting patient safety and data integrity.

Key responsibilities

• Conduct on‑site and remote monitoring visits using a risk‑based approach.
• Review source documentation, 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 study documentation within timelines.
• Communicate effectively with sites, sponsors and internal teams.
• Support site feasibility, investigator engagement and regulatory inspections.

Required profile

• Bachelor’s degree in Life Sciences, Nursing or a related healthcare field (or equivalent experience).
• Valid driver’s license where applicable.
• Willingness 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 risk‑based monitoring.
• Proficiency in Clinical Trial Management Systems (CTMS).
• Source documentation and CRF review expertise.
• Investigational product accountability management.
• Familiarity with regulatory inspections and audits.