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Thermo Fisher Scientific UK is seeking a Clinical Research Associate (Level II) for its Guangzhou location. The role involves conducting clinical monitoring and site management, ensuring compliance with protocols and regulations, and requires a background in life sciences or nursing.
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Job Summary
Perform and coordinate all aspects of the clinical monitoring and site management process, conducting remote or on-site visits to assess protocol and regulatory compliance.
Ensure trial conduct aligns with approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subject rights, well-being, and data reliability.
Monitor investigator sites using a risk-based approach, applying root cause analysis and critical thinking to identify failures and implement corrective actions.
Matching Summary
Match Score: 75
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Thermo Fisher Scientific UK is seeking a Clinical Research Associate (Level II) for its Guangzhou location. The role involves conducting clinical monitoring and site management, ensuring compliance with protocols and regulations, and requires a background in life sciences or nursing.
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Skills & Requirements
Must-have
Risk-based monitoring approach
ICH-GCP guidelines
Site processes specialist
Data accuracy through SDR, SDV and CRF review
Investigational product assessment
Audit readiness
Nice-to-have
Root cause analysis
Critical thinking and problem-solving skills
Collaborative relationships with investigational sites
Project publications/tools contribution
Process improvement initiatives
Key Requirements
Bachelor's degree in life sciences or RN certification