Fsp- Cra Ii (sydney)

Syneos Health

Sydney, Australia
Fully remote
Site qualification and initiation visits
Ich-gcp and good pharmacoepidemiology practice compliance
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 a Total Self culture where employees can authentically be themselves while accelerating the delivery of therapies.
  • Candidates must demonstrate good computer skills, critical thinking abilities, and the capacity to manage significant travel requirements.

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 Good Pharmacoepidemiology Practice compliance
  • Source document review and data verification
  • Informed consent process verification
  • Investigator Site File maintenance
  • Travel up to 75% on a regular basis

Nice-to-have

  • Mentorship of junior CRA staff
  • Experience with Real World Late Phase studies
  • Bid defense meeting participation
  • Collaboration with medical science liaisons
  • Process improvement suggestions

Key Requirements

  • Bachelor's degree or RN in related field
  • Knowledge of ICH Guidelines and GPP
  • Ability to travel up to 75%

Work Rights

Not specified

Tailored Resume

Cover Letter