Reporting directly to the Data and Safety Monitoring Committee (DSMC) Manager within the Abramson Cancer Center and indirectly to the Chief ACC Compliance Officer- Clinical Research, the Data and Safety Monitoring Committee (DSMC) Coordinator is responsible for assisting the DSMC Manager with all aspect of coordination of the DSMC monthly and ad hoc meetings. This includes sending quality, compliance and safety queries to investigator and following the queries through to conclusion; researching pharmacovigilance issues in medical records and corresponding regulations to determine compliance with regulations for appropriate safety case studies; providing reports to the DSMC manager; reviewing Quality Control and Assurance issues identified by the Manager of Regulatory Compliance and taking appropriate corrective actions as defined by the DSMC and collecting metrics to be reporting to the DSMC and CCO-CR. Ensuring DSMC activities comply with all NCI expectations, tracking data in proprietary systems and reporting as necessary; prepares meeting agendas; attends convened meetings; and maintains thorough and complete notes on the discussion. He/she prepares complete accurate minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in research, and a written summary of controverted issues and their resolution. The DSM C Coordinator prepares written correspondence to investigators of applicable DSMC actions and decisions. The DSMC Coordinator reviews and records exceptions, deviations, and independent safety reviews; maintains minutes, DSMC rosters, DSMC electronic files and all other required regulatory documents in compliance with federal regulations, institutional policies, and ACC SOPs. The DSMC Coordinator provides guidance on issues related to DSMC regulations and actions. The DSMC Coordinator participates, as assigned, in research community outreach and training activities; as well as DSMC member training and DSMC quality improvement initiatives including the review of existing DSMC policies and procedures. The DSMC Coordinator is responsible for maintaining a database of information related to DSMC activities and generating reports that are used by ACC leadership and the NCI.
Internal Number: 41295
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