Fsp- Cra Ii / Scra (melb/ Sydney)

Syneos Health

Melbourne, Australia
Fully remote
Site qualification and initiation visits
Ich-gcp and regulatory compliance knowledge
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 committed to building an inclusive culture where colleagues can authentically be themselves while driving patient progress.
  • Candidates must demonstrate the ability to manage required travel of up to 75% on a regular basis to support assigned sites.

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

  • Site qualification and initiation visits
  • ICH-GCP and regulatory compliance knowledge
  • Source document review and data verification
  • Protocol deviation assessment and resolution
  • Investigator Site File maintenance
  • 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 skills
  • Proactive site identification strategies

Key Requirements

  • Bachelor's degree or RN in related field
  • Knowledge of Good Clinical Practice/ICH Guidelines
  • Excellent computer skills and technology adaptability

Work Rights

Not specified

Tailored Resume

Cover Letter