Cra I / Cra Ii - Sponsor Dedicated - Bilingual French And English (home-based - Montreal, Quebec)

SyneosHealth

Montreal, Quebec, Canada
Fully remote
Bilingual french and english proficiency
Ich-gcp and good pharmacoepidemiology practice knowledge
Source document review and crf 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 that values diversity of thoughts, backgrounds, and perspectives to create an inclusive workplace.
  • Candidates must be able to manage travel of up to 75% regularly while adapting quickly to changing priorities to meet project objectives.

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

  • Bilingual French and English proficiency
  • ICH-GCP and Good Pharmacoepidemiology Practice knowledge
  • Source document review and CRF verification
  • Investigator Site File maintenance and reconciliation
  • Protocol deviation and pharmacovigilance assessment

Nice-to-have

  • Experience with Real World Late Phase study designs
  • Ability to train junior staff members
  • Proactive site identification based on local knowledge
  • Collaboration with medical science liaisons

Key Requirements

  • Bachelor's degree or RN in related field
  • Knowledge of ICH/GCP Guidelines
  • Excellent computer skills
  • Up to 75% travel capability

Work Rights

Not specified

Tailored Resume

Cover Letter