Typical Tasks of the RESQ Clincial Trail Monitor

  • Conduct monitoring at investigational sites in accordance with FDA CFR/ICH/GCP Guidelines, SOPs, and company policies. This includes Qualification, Initiation, Interim and Close-Out.
  • Facilitate Site Management on a regular basis to include weekly contact and follow-up.
  • Conduct SAE source verification, regulatory document review and collection.
  • Implement DCRs and provide assessment of DCR rates, as requested.
  • Interact with key CRO service providers regarding monitoring quality and project related issues.
  • Assess and resolve as applicable, trial logistics, implementation, conduct, screening, enrollment, and safety issues.
  • Conduct other trial related tasks or special projects as instructed by Clinical Operations Management.