Cra - Future Roles (spain)

Syneos Health

Spain
On-site
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 a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

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
  • Subject safety and data integrity assessment
  • Investigator Site File (ISF) review

Nice-to-have

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

Key Requirements

  • Bachelor's degree or RN
  • Knowledge of ICH/GCP Guidelines
  • Ability to manage required travel up to 75%

Work Rights

Not specified

Tailored Resume

Cover Letter