CRA (Level II)
Thermo Fisher Scientific · Zhejiang, China
Clinical OperationsFull timeCompany career page
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Role summary
Clinical Research Associate (Level II) at Thermo Fisher Scientific responsible for monitoring investigational sites, ensuring protocol compliance, and managing clinical trial documentation. The role involves on-site and remote monitoring activities, risk assessment, and coordination between sites and project teams across clinical trial operations.
What they're looking for
- Bachelor's degree in life sciences or registered nursing certification
- Approximately 1 year clinical research monitoring experience or PPD Drug Development Fellowship completion
- Proven clinical monitoring skills and ICH GCP knowledge
- Critical thinking, root cause analysis, and risk-based monitoring expertise
- Strong written and oral communication skills
- Medical/therapeutic area knowledge and medical terminology understanding
- Valid driver's license where applicable
What you'll be doing
- Conduct on-site and remote monitoring visits to assess protocol compliance and regulatory adherence
- Perform source document review, data verification, and investigational product inventory assessments
- Identify site process failures, perform root cause analysis, and implement corrective/preventive actions
- Initiate clinical trial sites, conduct investigator meetings, and manage trial closeout procedures
- Prepare trial status reports and maintain clinical trial management systems per study conventions
Privacy & handoff
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