Craii

Syneos Health

**
Ich/gcp guidelines
Protocol compliance
Site qualification and initiation
** Syneos Health is seeking a CRA II to join their fully remote Clinical Solutions team, where the focus is on driving customer success in drug development and commercialization. The ideal candidate will possess a strong understanding of Good Clinical Practice and have experience in site management and monitoring activities. **

Job Summary

  • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
  • Uses judgment and experience to evaluate overall performance of site and site staff and to develop action plans for serious 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

Match Score: 75

** Syneos Health is seeking a CRA II to join their fully remote Clinical Solutions team, where the focus is on driving customer success in drug development and commercialization. The ideal candidate will possess a strong understanding of Good Clinical Practice and have experience in site management and monitoring activities. **

Skills & Requirements

Must-have

  • ICH/GCP Guidelines
  • protocol compliance
  • site qualification and initiation
  • site monitoring and close-out
  • informed consent verification
  • subject safety and data integrity
  • Investigator Site File review

Nice-to-have

  • adapt to changing priorities
  • collaboration with project team
  • audit readiness standards
  • passion for developing people
  • inclusive culture

Key Requirements

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Knowledge of Good Clinical Practice/ICH Guidelines
  • Ability to manage required travel of up to 75%

Work Rights

Not specified

Tailored Resume

Cover Letter