Cra (level I)

Thermo Fisher Scientific UK

Remote, United Kingdom
Fully remote
Ich-gcp guidelines
Risk-based monitoring
Protocol compliance
Perform and coordinate different 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 different 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 internal project teams, and respond to company, client, and applicable regulatory requirements/audits/inspections.

Matching Summary

Perform and coordinate different 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

  • ICH-GCP guidelines
  • risk-based monitoring
  • protocol compliance
  • data accuracy
  • site management process
  • essential documents

Nice-to-have

  • root cause analysis
  • critical thinking
  • problem-solving skills
  • collaborative relationships
  • process improvement

Key Requirements

  • Bachelor's degree in life sciences or equivalent
  • Minimal clinical monitoring experience (2 years)
  • Valid driver's license

Work Rights

Not specified

Tailored Resume

Cover Letter