Fsp Cra (level Ii)

Thermo Fisher Scientific UK

Remote, United Kingdom
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 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.
  • Maintain regular contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording, while also participating in site initiation and close-out activities.

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 through SDR, SDV, CRF review
  • Investigator site monitoring
  • Trial initiation and close out

Nice-to-have

  • Root cause analysis skills
  • Critical thinking and problem-solving
  • Collaborative relationships with sites
  • Adaptable in wide range of scenarios
  • Contributes to process improvement

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