Clinical Trial QC Monitor-Remote

Performs comprehensive quality control (QC) monitoring of source documentation for City of Hope clinical trials. Reviews internal regulatory documents, protocols, amendments, correspondence and serious adverse event reports to maintain current knowledge and requirements of relevant protocols. Performs extensive QC visits to confirm appropriate source documentation in electronic health record (laboratory data, transfusion services records, and any other source used to produce study data) and in other electronic patient records (Florence eBinder) to confirm protocol compliance (including QC review of consent and eligibility criteria). Performs extensive review of case report forms and study data, utilizing medical records, laboratory data, transfusion services records, and any other source used to produce study data. Generates QC report, summarizing the findings of all deviations, discrepancies, and incorrect or missing source documentation. This role ensures the research enterprise maintains high standards of care and adheres to federal, state, and local regulations.

Duties & Responsibilities

• Verifies required reporting of Serious Adverse Events (SAE) to all applicable regulatory agencies (FDA, OBA, RAC, NIH, NCI) and external sponsors is completed in a timely manner.
• Reviews the original protocol and all amendments, noting dates, changes in eligibility criteria, and any modifications in treatment procedures to stay abreast with current protocol requirements to ensure adequate source documentation is available.
• Review source documentation forms prior to study start and electronic data capture system to verify consistency and accuracy regarding documentation collection and create study specific internal QC review and risk assessment plan.
• Identify, communicate and provide solutions for clinical trial issues and/or risks to study team and clinical trials leadership. Ensure quality deliverables, including identifying quality risks, and developing corrective action plans to prevent and/or correct deficiencies. Prepare and present reports on quality, risk management, and research compliance to clinical research leadership.
• Generates QC monitor reports, summarizing the findings of all protocol deviations, discrepancies, and incorrect or missing source documentation to provide to PI and study team. Independently investigate incomplete, inaccurate or missing source documentation to ensure accuracy and completeness of data. When direction is needed, provides training for sponsors, principal investigators, CRCs, and clinical research nurses.
• Serves as the subject matter expert for clinical research documentation improvement processes and regulations for regions, across the enterprise and provide recommendations to study teams and clinical research leadership. Proactively engages in internal working groups, projects, and relevant initiatives to implement change and to move QA initiatives forward, as well as to communicate to clinical research leadership on the various changes and rationale for change.
• May be required to travel to other participating sites up to perform QC review/monitoring of enrolled subjects as described above.

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