Donna Dorozinsky
Life Science Executive and Entrepreneur, Advisor on Clinical Quality Assurance
As the President & CEO of Just in Time GCP, Donna is responsible for running all facets of the business. She is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. Her vast experiences dealing with small to large Pharma companies, academic centers, regulatory agencies, CROs, and investigator sites provides her with the knowledge to assist research organizations in all areas of clinical compliance. She began her career in clinical research at GlaxoSmithKline where she spent 15 years in Phase I Clinical Research Operations. In 2005 Donna founded Just in Time GCP. In her capacity as President & CEO, she has built an organization that is highly respected within the clinical compliance and TMF management services industries. As a consultant, she has led many large projects performing operational gap analysis and implementing process improvement initiatives for sponsors, CROs and clinical sites. She has extensive experience in inspection readiness/preparation and has assisted organizations in developing and executing remediations across clinical systems, quality management systems, and TMF services.
Donna has presented numerous training programs in topics of GCP compliance, Quality Management Systems, Inspection Readiness, and TMF Management and is a dynamic educator. She is author of the TMF Chapter in Good Clinical Practice: A Question and Answer Guide, is a member of the TMF Reference Model Steering Committee, and was recently named an Ernst & Young Entrepreneur of the Year. Donna earned a BSN from Gwynedd Mercy University where she is currently serving as a member of the Board of Trustees and an MSN from Widener University.