Clinical Research Associate (CRA) – Senior Level
Thermo Fisher Scientific · Santiago
Job description
About the role
Thermo Fisher Scientific is seeking a Clinical Research Associate (CRA) – Senior level to join its Clinical Research team. You will monitor and manage clinical trial sites worldwide, ensuring compliance with protocols, ICH‑GCP, and regulatory standards 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 manage inventory records.
- Identify site issues, conduct root‑cause analysis, and support corrective actions.
- Prepare monitoring reports, follow‑up letters and maintain essential documents per ICH‑GCP.
- Maintain study records in CTMS and other trial management tools.
- Support regulatory inspections, audits and quality initiatives.
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).
- Familiarity with case report forms (CRFs) and investigational product accountability.
What we offer
- Opportunity to work on global clinical trials across more than 100 countries.
- Collaborative environment with cross‑functional teams.
- Professional development within a leading life‑science company.
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Published 1 month ago
Expires 2 weeks from now
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Thermo Fisher Scientific
Santiago
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