Fsp Cra Level Ii

PPD (Thermo Fisher) UK

Guangzhou, China
**
Risk-based monitoring approach
Ich-gcp guidelines
Site processes specialist
** PPD (Thermo Fisher) is seeking a Clinical Research Associate (Level II) based in Guangzhou, China, to oversee clinical monitoring and site management processes for clinical trials. The role requires experience in clinical monitoring, strong critical thinking skills, and a commitment to ensuring compliance with regulatory standards. **

Job Summary

  • Perform and coordinate all aspects of the clinical monitoring and site management process, ensuring protocol and regulatory compliance.
  • Conduct remote or on-site visits, assess data accuracy, and manage required documentation to guarantee subjects' rights, well-being, and data reliability.
  • Develop collaborative relationships with investigational sites and ensure audit readiness.

Matching Summary

Match Score: 75

** PPD (Thermo Fisher) is seeking a Clinical Research Associate (Level II) based in Guangzhou, China, to oversee clinical monitoring and site management processes for clinical trials. The role requires experience in clinical monitoring, strong critical thinking skills, and a commitment to ensuring compliance with regulatory standards. **

Skills & Requirements

Must-have

  • Risk-based monitoring approach
  • ICH-GCP guidelines
  • Site processes specialist
  • Data accuracy
  • Investigational product assessment
  • Audit readiness

Nice-to-have

  • Collaborative relationships with sites
  • Root cause analysis
  • Critical thinking and problem-solving skills
  • Effective communication

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter