FSP CRA (Level II)
Thermo Fisher Scientific · Zhejiang, China
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Role summary
Clinical Research Associate at Thermo Fisher Scientific responsible for monitoring investigational sites, ensuring protocol compliance, and managing clinical trial documentation. Conducts remote and on-site visits to assess regulatory adherence, data integrity, and subject safety across multiple sponsor environments.
What they're looking for
- Knowledge of ICH-GCP guidelines and applicable clinical research regulations
- Experience with clinical monitoring, site management, and protocol compliance assessment
- Proficiency in root cause analysis and problem-solving methodologies
- Strong written and verbal communication skills for documentation and stakeholder engagement
- Familiarity with clinical trial management systems and data verification processes
What you'll be doing
- Conduct risk-based monitoring visits to investigational sites using on-site and remote approaches
- Review source documents, case report forms, and investigational product records for accuracy and compliance
- Document findings in reports and escalate deficiencies to clinical management for timely resolution
- Initiate and close out trial sites, coordinate investigator meetings, and maintain inter-visit communication
- Track trial status and progress, updating study systems and reporting to clinical management as required
Privacy & handoff
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