Experienced Bilingual Clinical Research Associate (cra Ii, Sr Cra, Pcra) - Montreal, Qc

Thermo Fisher Scientific UK

Montreal, QC, Canada
Remote
Risk-based monitoring approach
Ich-gcp guidelines
Site processes specialist
Perform and coordinate all aspects of the clinical monitoring and site management process, assessing protocol and regulatory compliance

Job Summary

  • Perform and coordinate all aspects of the clinical monitoring and site management process, assessing 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 to confirm protocol adherence, issue resolution, and timely data recording, while ensuring audit readiness.

Matching Summary

Perform and coordinate all aspects of the clinical monitoring and site management process, assessing protocol and regulatory compliance.

Skills & Requirements

Must-have

  • Risk-based monitoring approach
  • ICH-GCP guidelines
  • Site processes specialist
  • Investigational product assessment
  • Essential document completion

Nice-to-have

  • Root cause analysis
  • Critical thinking and problem-solving
  • Collaborative relationships with 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 where applicable
  • English and French language skills

Work Rights

Not specified

Tailored Resume

Cover Letter