- Regulatory Manager
Anne Franklin began her introduction to working in clinical research at the National Cancer Institute, located in Rockville, MD. There, she worked as a Research Assistant, aiding Principal Investigators in clinical research studies of families at high risk of cancer including melanoma skin cancer, breast cancer and lymphoma cancer studies. Anne maintained subject research records, collected pathology materials and processed requisitions for biological specimens.
In 2008, Anne accepted a position at Walter Reed Medical Center as a Protocol Administrator. Her responsibilities included initial review of research protocols for the Department of Clinical Investigation, editing consent forms, processing protocol amendments, and scheduling research studies for Board review.
Anne began working at Sheridan Clinical Research, Inc. in May 2012 as a Regulatory Analyst in various therapeutic areas: Women’s Health, Gynecologic Oncology, Neonatology, Mental Health, and Neurology. Under this capacity, she maintained regulatory binders, prepared IRB submissions and documents, maintained enrollment charts and department metrics, and assisted in protocol preparation for investigator initiated studies.
Anne leveraged her diverse clinical research background to quickly excel in regulatory and became a Regulatory Manager in August 2015. As a Regulatory Manager at Segal Trials, Anne provides regulatory oversight for multi-research sites, IRB submission process and coordinates study start-up activities. Anne successfully juggles several projects across multiple sites, supervises information between internal sites and external customers, such as, CROs, sponsors and IRBs, and ensures IRB submissions are in compliance with ICH/GCP guidelines, IRB requirements and FDA regulations. She is humbly dedicated to delivering optimal leadership and support with her teams making sure everyone is aware of Regulatory Department’s expectations and standards.
Anne holds a Master of Science Degree in Biomedical from Barry University and a member of Association of Clinical Research Professionals (ACRP).