FSP CRA (Level II)
Thermo Fisher Scientific · Shanghai, China
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Role summary
Thermo Fisher Scientific seeks a Clinical Research Associate (Level II) to conduct remote and on-site monitoring of investigational sites, ensuring protocol compliance and data integrity across clinical trials. The role involves site management, regulatory documentation oversight, and collaboration with sponsors and investigative teams.
What they're looking for
- Bachelor's degree in life sciences or registered nursing certification
- Approximately one year clinical research monitoring experience or equivalent
- Proficiency in ICH-GCP guidelines, applicable regulations, and clinical trial procedures
- Strong critical thinking, root cause analysis, and problem-solving capabilities
- Excellent written and oral communication skills with medical personnel
- Risk-based monitoring knowledge and competency with clinical trial management systems
What you'll be doing
- Conduct on-site and remote monitoring visits to assess protocol and regulatory compliance at investigational sites
- Perform data accuracy reviews including source document verification and case report form evaluation
- Develop and implement corrective and preventive actions to address site deficiencies and compliance gaps
- Maintain essential regulatory documentation and track trial status for clinical management reporting
- Facilitate communication among investigative sites, sponsors, and project team members
Privacy & handoff
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