FSP CRA (Level II)
Thermo Fisher Scientific · Zhejiang, China
Clinical OperationsFull timeCompany career page
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Role summary
Thermo Fisher Scientific seeks a Level II Clinical Research Associate to monitor investigational sites and manage clinical trial compliance in Zhejiang, China. The role involves remote and on-site monitoring activities, regulatory assessments, and coordination across multiple stakeholders to ensure protocol adherence and data integrity.
What they're looking for
- Bachelor's degree in life sciences or registered nursing certification
- Approximately 1 year of clinical research monitoring experience or completion of drug development fellowship
- Strong understanding of ICH-GCP guidelines, regulations, and medical terminology
- Demonstrated critical thinking, root cause analysis, and risk-based monitoring skills
- Excellent written and oral communication abilities with medical personnel
- Proficiency in organizational skills, attention to detail, and adaptability
- Valid driver's license where applicable
What you'll be doing
- Conduct risk-based monitoring visits to assess protocol compliance and regulatory adherence at investigational sites
- Perform data validation through source document review and case report form assessment via on-site and remote activities
- Initiate clinical trial sites and conduct investigator meetings to ensure qualified site participation and compliance
- Document observations in monitoring reports and escalate deficiencies to clinical management with timely follow-up
- Maintain essential documentation completeness and provide trial status updates to clinical team management
Privacy & handoff
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