Craii/sr Cra (athens)sponsor Dedicated

Syneos Health

Athens, GA, US
Fully remote
Site qualification and initiation visits
Ich-gcp and gpp regulatory compliance
Source document review and data verification
The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance

Job Summary

  • The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance.
  • Syneos Health is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success and changing lives through innovative clinical development.
  • Candidates must demonstrate excellent communication skills and the ability to manage travel of up to 75% while maintaining strict confidentiality of patient data.

Matching Summary

The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance.

Skills & Requirements

Must-have

  • Site qualification and initiation visits
  • ICH-GCP and GPP regulatory compliance
  • Source document review and data verification
  • Informed consent process verification
  • Investigator Site File maintenance
  • Travel up to 75% required

Nice-to-have

  • Experience with Real World Late Phase studies
  • Chart abstraction activities
  • Training junior staff capabilities
  • Collaboration with Medical Science Liaisons
  • Proactive site identification skills

Key Requirements

  • Bachelor's degree or RN in related field
  • Knowledge of Good Clinical Practice/ICH Guidelines
  • US work authorization required for site access

Work Rights

Must be eligible for US facility access; citizenship status not explicitly defined but US only role

Tailored Resume

Cover Letter