Cra - Future Roles (bulgaria)

Syneos Health

Remote
Remote
Ich-gcp and/or gpp compliance
Site qualification and initiation
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.
  • Syneos Health is committed to our Total Self culture – where you can authentically be yourself, uniting us globally, and dedicated to taking care of our people.

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
  • Monitoring and close-out visits
  • Protocol deviation assessment
  • Investigational product management
  • Investigator Site File maintenance

Nice-to-have

  • Adaptability to changing priorities
  • Support subject recruitment strategies
  • Audit readiness standards

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter