FSP CRA (Level II)
Thermo Fisher Scientific · Zhejiang, China
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Thermo Fisher Scientific seeks a Level II Clinical Research Associate to monitor investigational sites, ensure protocol compliance, and manage clinical trial documentation. The role involves remote and on-site visits across multiple trials, coordinating with sponsors and sites to maintain data integrity and regulatory standards.
What they're looking for
- Bachelor's degree in life sciences or registered nursing certification
- Approximately 1 year of clinical research monitoring experience or fellowship completion
- Demonstrated knowledge of ICH-GCP guidelines and applicable regulations
- Critical thinking and root cause analysis skills for problem-solving
- Strong written and oral communication abilities
- Risk-based monitoring competency and familiarity with clinical trial systems
- Valid driver's license where applicable
What you'll be doing
- Conduct on-site and remote monitoring visits using risk-based approach to assess protocol and regulatory compliance
- Review subject data records, source documentation verification, and case report forms for accuracy
- Identify site process failures and implement corrective/preventive actions to resolve compliance issues
- Initiate trial sites, conduct investigator meetings, and manage trial closeout procedures
- Prepare status reports, track progress updates, and facilitate communication between sites and sponsors
Privacy & handoff
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