Sr Cra (level I)

Thermo Fisher Scientific UK

Remote, United Kingdom
Fully remote
Risk-based monitoring approach
Ich-gcp guidelines
Root cause analysis
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.
  • Facilitate effective communication between investigative sites, the client company, and the project team, and respond to company, client, and applicable 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
  • Root cause analysis
  • Data accuracy review
  • Investigator site communication

Nice-to-have

  • Customer focus and listening skills
  • Flexibility and adaptability
  • Process improvement contributions

Key Requirements

  • 2+ years clinical research monitor experience
  • Bachelor's degree in life sciences or equivalent
  • Registered Nursing certification or equivalent
  • Valid driver's license where applicable

Work Rights

Not specified

Tailored Resume

Cover Letter