Cra Ii - Fsp

Syneos Health

Client, ,
On-site
Ich-gcp and/or gpp compliance
Site qualification and initiation
Interim monitoring and close-out visits
Performs site qualification, initiation, monitoring, management, and close-out visits ensuring regulatory and protocol compliance

Job Summary

  • Performs site qualification, initiation, monitoring, management, and close-out visits ensuring regulatory and protocol compliance.
  • Assesses site processes, verifies data accuracy, and drives query resolution to closure within agreed timelines.
  • Supports subject recruitment, retention, and awareness strategies, and provides guidance towards audit readiness standards.

Matching Summary

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

Skills & Requirements

Must-have

  • ICH-GCP and/or GPP compliance
  • Site qualification and initiation
  • Interim monitoring and close-out visits
  • Source document review
  • CRF data verification
  • Query resolution
  • Investigator Site File review
  • Subject safety and data integrity assessment

Nice-to-have

  • Adapt to changing priorities
  • Support subject recruitment strategies
  • Audit readiness guidance
  • Real World Late Phase knowledge

Key Requirements

  • Bachelor’s degree or RN in a related field
  • Knowledge of Good Clinical Practice/ICH Guidelines
  • Ability to manage required travel of up to 75%

Work Rights

Not specified

Tailored Resume

Cover Letter