Sr Cra Ii - Fsp Model - Poland - Homebased

Syneos Health

Poland
Remote
Ich-gcp and gpp compliance
Site qualification and initiation
Remote and on-site monitoring
Perform site qualification, initiation, monitoring, management, and close-out visits ensuring regulatory and protocol compliance

Job Summary

  • Perform site qualification, initiation, monitoring, management, and close-out visits ensuring regulatory and protocol compliance.
  • Assess site processes, conduct source document review, and verify data accuracy and completeness, driving query resolution.
  • Support subject recruitment, retention, and awareness strategies, and provide guidance towards audit readiness.

Matching Summary

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

Skills & Requirements

Must-have

  • ICH-GCP and GPP compliance
  • Site qualification and initiation
  • Remote and on-site monitoring
  • Subject safety and data integrity assessment
  • Investigator Site File (ISF) review
  • Subject recruitment and retention support

Nice-to-have

  • Agile and driven to deliver
  • Passionate problem solvers
  • Collaborate with passionate problem solvers
  • Adapt to changing priorities

Key Requirements

  • Bachelor's degree or RN or equivalent
  • Knowledge of GCP/ICH Guidelines
  • Moderate critical thinking skills
  • Ability to manage up to 75% travel

Work Rights

Not specified

Tailored Resume

Cover Letter