Melissa Epstein

Executive Director, Human Research Protection & Compliance @Joan & Sanford I. Weill Medical College Of Cornell University

New York, NY, US

Provide strategic oversight for a comprehensive Human Research Protection Program (HRPP), directly impacting the regulatory and ethical conduct of clinical trials across WCM, encompassing IRB, Data Safety Monitoring Committees (DSMCs), and ClinicalTrials.gov reporting.Spearheaded a comprehensive IRB process overhaul, permanently eliminating a historic backlog and reducing review times to align with peer institutions.Developed and enhanced IRB resources, including SOPs, application materials, and educational programs, ensuring compliant and efficient submission processes for clinical research teams.Stabilized and professionalized HRPP departmental staffing through strategic reorganization, creating a more agile leadership team that enhanced responsiveness and operational efficiency for clinical research support.Established an Executive IRB to streamline the review of critical reportable events, minimizing potential delays in ongoing clinical trials and ensuring rapid resolution of safety and compliance issues.Developed and implemented a leadership development program focused on change management, project prioritization, and root cause analysis, directly equipping teams to optimize complex clinical research workflows and adapt to evolving regulatory landscapes.Established a joint consultation process with Columbia University, optimizing collaborative research initiatives across NewYork Presbyterian.Stabilized and enhanced DSMC processes, implementing workload delegation and tracking to improve operational flexibility and oversight of patient safety in ongoing clinical trials.Oversaw development of a comprehensive DSMC toolkit (SOPs, templates, guidelines), ensuring robust oversight and compliance with regulatory requirements.Member of the CARE-Q Board of Governors, an independent accreditation program for HRPPs, underscoring expertise in human research protection and commitment to operational excellence in clinical research.

University of California, Los Angeles

PhD

Albert Einstein College of Medicine

Master’s Degree

University of Pennsylvania

BA

University of Oxford

Diploma