Cra Ssu - Experience In Regulatory And Monitoring - Mexico Home Based

Syneos Health

Mexico
Remote
Ich-gcp and/or gpp compliance
Site qualification and initiation
Interim monitoring and close-out visits
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.
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

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 and initiation
  • Interim monitoring and close-out visits
  • Source document review
  • Investigational product verification
  • Investigator Site File (ISF) review
  • Subject/patient recruitment support

Nice-to-have

  • Agile and driven to deliver
  • Passion for developing people
  • Inclusive culture
  • Adapt to changing priorities

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter