Senior Clinical Research Associate (Level I)
Thermo Fisher Scientific
Description du poste
About the role
Thermo Fisher Scientific is seeking a Senior Clinical Research Associate (Level I) to support the delivery of global clinical trials. In this position you will act as a key liaison between investigational sites, sponsors and internal project teams, ensuring that studies are conducted according to protocol, regulatory standards and company procedures.
Key responsibilities
- Plan and execute remote and on‑site monitoring visits using a risk‑based approach.
- Perform source data review, source data verification and case report form checks to guarantee data quality.
- Verify investigational product accountability and manage inventory records.
- Identify site deficiencies, document findings and drive corrective and preventive actions.
- Maintain regular communication with sites to support protocol compliance and timely data entry.
- Ensure study documentation meets regulatory requirements and support audit/inspection readiness.
- Provide status updates to the Clinical Team Manager and keep study systems, including the Clinical Trial Management System, up to date.
Required profile
- Minimum 3‑5 years of experience in clinical monitoring for pharmaceutical or biotechnology studies.
- Strong knowledge of ICH‑GCP, applicable regulations and standard operating procedures.
- Excellent analytical and problem‑solving abilities with a focus on data integrity.
- Effective communication skills for interaction with investigators and cross‑functional teams.
Required skills
- Proficiency with Clinical Trial Management Systems (CTMS).
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