Fsp Cra (level 2)

Thermo Fisher Scientific UK

Beijing, China
Fully remote
Risk-based monitoring approach
Ich-gcp guidelines
Site processes specialist
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

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 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.
  • Maintain regular contact with investigative sites, facilitate communication between sites, client, and project team, and respond to regulatory requirements/audits/inspections.

Matching 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.

Skills & Requirements

Must-have

  • Risk-based monitoring approach
  • ICH-GCP guidelines
  • Site processes specialist
  • Data accuracy review
  • Investigational product assessment
  • Essential documents completion

Nice-to-have

  • Root cause analysis
  • Critical thinking
  • Problem-solving skills
  • Collaborative relationships
  • Customer focus
  • Flexibility and adaptability

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter