Fsp Cra Ii/ Snr Cra

Syneos Health

Fully remote
Ich-gcp and/or gpp compliance
Site qualification and initiation visits
Protocol deviation assessment
Performs site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance

Job Summary

  • Performs site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (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.
  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

Matching Summary

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

Skills & Requirements

Must-have

  • ICH-GCP and/or GPP compliance
  • Site qualification and initiation visits
  • Protocol deviation assessment
  • Source document review
  • CRF data verification
  • Investigational product management
  • Investigator Site File maintenance

Nice-to-have

  • Agile and driven to accelerate delivery
  • Passionate about changing lives
  • Total Self culture
  • Diversity of thoughts and backgrounds
  • Problem solvers and innovators

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter