Fsp Cra Level Ii

Thermo Fisher Scientific UK

Guangzhou, China
**
Risk-based monitoring approach
Ich-gcp guidelines
Site processes specialist
** 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. **

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

** 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. **

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
  • 1 year clinical research monitor experience
  • Valid driver's license

Work Rights

Not specified

Tailored Resume

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