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 Clinical Research Associate (Level II) to monitor investigational sites, ensure protocol compliance, and manage clinical trial documentation. The role involves coordinating remote and on-site visits, conducting data quality reviews, and maintaining regulatory adherence across multiple trial sites.
What they're looking for
- Bachelor's degree in life sciences or registered nursing certification
- Approximately one year clinical research monitoring experience or PPD Drug Development Fellowship completion
- Proven clinical monitoring skills and ICH-GCP knowledge
- Strong critical thinking, root cause analysis, and problem-solving abilities
- Proficiency with risk-based monitoring concepts and processes
- Excellent written and oral communication skills
- Valid driver's license where applicable
What you'll be doing
- Conduct remote and on-site site visits using risk-based monitoring approach to assess protocol and regulatory compliance
- Perform data accuracy reviews including source document review, verification, and case report form assessment
- Initiate and close out clinical trial sites while ensuring essential regulatory documents are complete and properly filed
- Escalate identified deficiencies to clinical management and track corrective actions to resolution
- Maintain communication with investigational sites between monitoring visits and provide trial status updates to management
Privacy & handoff
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