Upvote
Downvote
Clinical Research Monitor
Share Job
- Suggest Revision
- The Clinical Research Monitor will work under the Executive Director of Clinical Trial Operations and the Associate Director of Clinical Trial Operations to oversee activity at Alliance for Clinical Trials in Oncology sites participating in Alliance Foundation Trials (AFT) clinical trials.
- This includes Source Data Validation (SDV) of clinical study data entered on the Case Report Forms (CRF) in the Electronic Data Capture (EDC) system, review and reconciliation of the Investigational Site File (ISF) with the Electronic Trial Master File (eTMF), ensure proper documentation of Investigational Product (IP), and ensure overall adherence to protocol procedures.
- The Clinical Research Monitor works in partnership with the AFT Project Manager and individual study teams to complete all site monitoring activities across assigned AFT projects and ensures all participating sites are compliant with Good Clinical Practice (GCP), SOPs, policies, and regulatory requirements throughout the life of assigned clinical trials.
- Monitor clinical trial progress, in conjunction with the AFT In-House Clinical Research Associate (IHCRA), through a combination of remote data review and remote/on-site monitoring visits.
- Verify that trial data entered in the EDC is consistent with patient clinical notes and other source documentation (SDV).
Expired 5 days agoInactive Job
Similar Job
Relevance
Active