FSP CRA (Level II)
Thermo Fisher Scientific · Guangdong, China
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Role summary
Thermo Fisher Scientific seeks a Level II Clinical Research Associate to conduct remote and on-site monitoring of investigational sites across clinical trials. The role involves assessing protocol compliance, managing documentation, and ensuring data integrity while collaborating with sponsors and sites across multiple monitoring environments.
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
- Valid driver's license where applicable
- Demonstrated knowledge of ICH-GCP guidelines, regulations, and clinical monitoring procedures
- Critical thinking, root cause analysis, and risk-based monitoring proficiency
- Strong oral and written communication skills with medical personnel
- Proficiency in clinical trial management systems and computer applications
What you'll be doing
- Conduct risk-based site monitoring visits to assess protocol and regulatory compliance using root cause analysis
- Perform data source document review, SDV, and CRF verification through on-site and remote activities
- Initiate and close out clinical trial sites following relevant procedures and regulatory requirements
- Track trial status and provide progress reports to clinical management and sponsors
- Facilitate communication between investigative sites, sponsors, and project team members
Privacy & handoff
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