Fsp Cra Level Ii

Thermo Fisher Scientific UK

Chengdu, China
On-site
Risk-based monitoring approach
Ich-gcp guidelines
Site processes specialist
Thermo Fisher Scientific is seeking a Clinical Research Associate (Level II) for their Chengdu, China location. The role involves coordinating clinical trials, ensuring compliance with protocols and regulations, and maintaining site relationships while offering the opportunity to work with leading pharmaceutical and biotech companies

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 that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability.
  • Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis and problem-solving skills to identify site processes failures and corrective/preventive actions.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a Clinical Research Associate (Level II) for their Chengdu, China location. The role involves coordinating clinical trials, ensuring compliance with protocols and regulations, and maintaining site relationships while offering the opportunity to work with leading pharmaceutical and biotech companies.

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

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

Cover Letter