Cra Ssu - Experience In Regulatory And Monitoring - Sponsor Dedicated - Colombia Home Based

Syneos Health

Colombia
Remote
Regulatory and monitoring experience
Ich-gcp and gpp compliance
Site qualification and initiation
Perform site qualification, initiation, monitoring, and close-out visits ensuring regulatory and protocol compliance

Job Summary

  • Perform site qualification, initiation, monitoring, and close-out visits ensuring regulatory and protocol compliance.
  • Assess site processes, conduct source document reviews, and verify clinical data accuracy and completeness.
  • Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes to ensure compliance.

Matching Summary

Perform site qualification, initiation, monitoring, and close-out visits ensuring regulatory and protocol compliance.

Skills & Requirements

Must-have

  • Regulatory and monitoring experience
  • ICH-GCP and GPP compliance
  • Site qualification and initiation
  • Source document review
  • Investigational product management
  • Investigator Site File (ISF) maintenance

Nice-to-have

  • Adaptable to changing priorities
  • Proactive problem-solving
  • Collaborative team player

Key Requirements

  • Bachelor's degree or RN
  • Knowledge of GCP/ICH Guidelines
  • Ability to manage required travel up to 75%

Work Rights

Not specified

Tailored Resume

Cover Letter