Fsp Cra (level Ii)

Thermo Fisher Scientific UK

Shanghai, China
**
Risk-based monitoring approach
Ich-gcp guidelines
Root cause analysis
** Thermo Fisher Scientific UK is seeking a Level II Clinical Research Associate in Shanghai, China, to oversee clinical monitoring and site management processes. The role involves ensuring compliance with protocols, managing documentation, and maintaining relationships with investigative sites, requiring strong critical thinking and communication skills. **

Job Summary

  • Perform and coordinate all aspects of the clinical monitoring and site management process, ensuring trial compliance with protocols, regulations, and SOPs.
  • Conduct remote or on-site visits to assess protocol and regulatory compliance, manage documentation, and ensure data reliability.
  • Develop collaborative relationships with investigational sites and ensure audit readiness for the trial.

Matching Summary

Match Score: 75

** Thermo Fisher Scientific UK is seeking a Level II Clinical Research Associate in Shanghai, China, to oversee clinical monitoring and site management processes. The role involves ensuring compliance with protocols, managing documentation, and maintaining relationships with investigative sites, requiring strong critical thinking and communication skills. **

Skills & Requirements

Must-have

  • Risk-based monitoring approach
  • ICH-GCP guidelines
  • Root cause analysis
  • Data accuracy assessment
  • Investigational product assessment
  • Site processes specialist

Nice-to-have

  • Collaborative relationships with sites
  • Audit readiness
  • Project publications/tools contribution

Key Requirements

  • Bachelor's degree in life sciences or equivalent
  • 1 year clinical research monitor experience
  • Valid driver's license

Work Rights

Not specified

Tailored Resume

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