Cra Ii - Sr.cra I For Fsp Bu, South Korea

SyneosHealth

South Korea
Fully remote
Site qualification and initiation visits
Ich-gcp and regulatory compliance knowledge
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 committed to a Total Self culture that values diversity of thoughts, backgrounds, and perspectives to create an inclusive workplace.
  • Candidates must be able to manage required travel of up to 75% on a regular basis while maintaining project timelines and objectives.

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 regulatory compliance knowledge
  • Source document review and data verification
  • Investigator Site File maintenance
  • Protocol deviation assessment
  • Query resolution techniques
  • Up to 75% travel requirement

Nice-to-have

  • Experience with Real World Late Phase studies
  • Chart abstraction activities
  • Training junior staff capabilities
  • Local treatment pattern knowledge
  • Patient advocacy network awareness
  • Collaboration with medical science liaisons

Key Requirements

  • Bachelor's degree or RN in related field
  • Knowledge of Good Clinical Practice/ICH Guidelines
  • Excellent computer skills and technology adaptability

Work Rights

Not specified

Tailored Resume

Cover Letter