Clinical Trial Monitor
Sidra Medicine
منذ 5 يوم
source :

Key RoleAccountabilities

  • Verifies that all withdrawals and dropouts of enrolledsubjects from the trial are reported and explained on theCRFs.
  • Checks whether all adverse events (AEs)are appropriately reported within the time periods required by GCP,the protocol, the IRB / IEC, the sponsor, and the applicableregulatory requirement(s).
  • Verifies that theinvestigator provides all the required reports, notifications,applications, and submissions and that these documents areaccurate, complete, timely, and legible, dated, and identify thetrial.
  • Determines whether the investigator ismaintaining the essential documents.
  • Meetsexpected timelines for completion of monitoring activities andsubmission of written monitoring reports.
  • Sumsup the findings of the monitoring process and reports to the nextin line authority for resolution and corrective / preventiveactions.
  • Communicates deviations from theprotocol, SOPs, GCP, and the applicable regulatory requirements tothe investigator and ensures appropriate action is designed toprevent recurrence of the detected deviations.
  • Adheres to Sidra’s standards as they appear inthe Code of Conduct and Conflict of Interest policies
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