Clinical Research Associate Ii / Cra I - Sponsor Dedicated (home-based In Toronto)

Syneos Health

Toronto, Ontario, Canada
Remote
Ich-gcp and/or gpp compliance
Site qualification, initiation, monitoring, and close-out
Source document review
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance

Job Summary

  • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
  • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
  • Supports subject/patient recruitment, retention and awareness strategies and manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

Matching Summary

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.

Skills & Requirements

Must-have

  • ICH-GCP and/or GPP compliance
  • Site qualification, initiation, monitoring, and close-out
  • Source document review
  • Investigational product verification
  • Investigator Site File review

Nice-to-have

  • Agile and driven to deliver
  • Passionate problem solvers
  • Inclusive culture
  • Adapt to changing priorities

Key Requirements

  • Bachelor’s degree or RN in a related field
  • Knowledge of ICH Guidelines
  • Ability to manage required travel of up to 75%

Work Rights

Not specified

Tailored Resume

Cover Letter