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SyneosHealth

Fully remote
Ich-gcp and regulatory compliance knowledge
Site qualification and initiation experience
Source document review and data verification
The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance

Job Summary

  • The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance.
  • Syneos Health is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success and changing lives through innovative therapies.
  • Candidates must demonstrate excellent computer skills, manage travel of up to 75%, and possess a Bachelor's degree or RN in a related field.

Matching Summary

The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance.

Skills & Requirements

Must-have

  • ICH-GCP and regulatory compliance knowledge
  • Site qualification and initiation experience
  • Source document review and data verification
  • Protocol deviation assessment skills
  • Travel up to 75% required

Nice-to-have

  • Experience with real world late phase studies
  • Chart abstraction and data collection skills
  • Ability to train junior staff members
  • Strong interpersonal communication abilities
  • Proactive site identification capabilities

Key Requirements

  • Bachelor's degree or RN in related field
  • Knowledge of ICH/GCP Guidelines
  • US work authorization required

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter