Clinical Research Associate Ii

PPD (Thermo Fisher)

Fully remote
Risk-based monitoring approach
Ich-gcp guidelines compliance
Investigational product assessment
Perform and coordinate all aspects of the clinical monitoring and site management process

Job Summary

  • Perform and coordinate all aspects of the clinical monitoring and site management process.
  • Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
  • 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.

Matching Summary

Perform and coordinate all aspects of the clinical monitoring and site management process.

Skills & Requirements

Must-have

  • Risk-based monitoring approach
  • ICH-GCP guidelines compliance
  • Investigational product assessment
  • Site process compliance
  • Data accuracy through review

Nice-to-have

  • Collaborative relationships with sites
  • Project publications/tools contribution
  • Process improvement initiatives

Key Requirements

  • Bachelor's degree in life sciences or RN certification
  • 1 year clinical research monitor experience
  • Valid driver's license

Work Rights

Not specified

Tailored Resume

Cover Letter