Cra (level Ii) - Fsp Vaccine - Central Us

PPD (Thermo Fisher) UK

Fully remote
Risk-based monitoring approach
Root cause analysis
Ich-gcp guidelines
Perform and coordinate all aspects of the clinical monitoring and site management process, including 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, including 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.
  • Offers a comprehensive Total Rewards package including medical, dental, vision plans, paid time off, paid holidays, paid parental leave, and retirement savings programs.

Matching Summary

Perform and coordinate all aspects of the clinical monitoring and site management process, including remote or on-site visits to assess protocol and regulatory compliance.

Skills & Requirements

Must-have

  • Risk-based monitoring approach
  • Root cause analysis
  • ICH-GCP guidelines
  • Investigational product assessment
  • Essential document completion

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter