Nicole M.

About Nicole M.

Nicole works for the University Hospitals (UH), Seidman Cancer Center (SCC), Clinical Trials Unit (CTU) as the regulatory supervisor leading 17 regulatory coordinators with over 400 cancer studies. Nicole was quickly recognized for strong leadership and critical thinking skills, leading to a promotion in less than 2 years within the CTU. Nicole also manages Phase 1 - 3, GI, Brain, Breast, hematology, and BMT cancer trials. Nicole supervises locally held IND, industry, and NIH funded studies. In addition to managing a large study portfolio and a high number of direct reports, Nicole has streamlined numerous reg process and decreased reg findings during audits to less than 5%. The CTU is part of the Case Comprehensive Cancer Center that includes Cleveland Clinic\'s Cancer Center. Nicole works closely with Case and Cleveland Clinic’s regulatory directors to ensure all regulatory cooperative studies are cohesive. Nicole has degrees in biochemistry and clinical research and holds the SoCRA CCRP certification. Prior to UH, Nicole worked in the Office of Regulatory Affairs (ORA) for the FDA, as a regulatory specialist.

Experience

1. Clinical Research Regulatory Supervisor

   University Hospitals

   Nov 2022 — Present