Fsp Cra (sponsor: Gsk) ─ With Sign-on Bonus

PPD (Thermo Fisher)

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

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
  • Root cause analysis
  • ICH-GCP guidelines
  • Investigational product assessment
  • Site processes specialist

Nice-to-have

  • Collaborative relationships with sites
  • Audit readiness
  • Problem-solving skills
  • Adaptable in wide range of scenarios

Key Requirements

  • Bachelor's degree in life sciences or equivalent
  • 1-2 years of independent monitoring experience
  • Understanding of ICH-GCP, KGCP requirements
  • Fluency in English

Work Rights

Not specified

Tailored Resume

Cover Letter