Cra (level Ii) - Fsp Vaccine - Central Us

PPD (Thermo Fisher) UK

Chicago, United States
On-site
Risk-based monitoring approach
Ich-gcp guidelines
Protocol and regulatory compliance
Perform and coordinate all aspects of the clinical monitoring and site management process, ensuring adherence to protocol, regulations, and SOPs

Job Summary

  • Perform and coordinate all aspects of the clinical monitoring and site management process, ensuring adherence to protocol, regulations, and SOPs.
  • Conduct remote or on-site visits to assess compliance, manage documentation, and ensure data reliability and subject well-being.
  • The company offers a comprehensive Total Rewards package including medical, dental, vision plans, paid time off, holidays, parental leave, and retirement savings programs.

Matching Summary

Perform and coordinate all aspects of the clinical monitoring and site management process, ensuring adherence to protocol, regulations, and SOPs.

Skills & Requirements

Must-have

  • Risk-based monitoring approach
  • ICH-GCP guidelines
  • Protocol and regulatory compliance
  • Investigational product assessment
  • Site processes specialist

Nice-to-have

  • Root cause analysis
  • Critical thinking and problem-solving
  • Collaborative relationships with sites
  • Audit readiness

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