Donna W. Dorozinsky BSN, RN, MSN, CCRC

Donna is a business consultant who has over 20 years of experience in clinical research with a strong focus in Phase I operations. Her energy and enthusiasm strike a balance with her in-depth knowledge of clinical research operations and Good Clinical Practice, and experience in project management. She began her career in clinical research at GlaxoSmithKline where she spent 15 years in Phase I Clinical Research Operations. In 2005 Donna founded DWD & Associates. In her capacity as President, she has led several large projects performing operational assessments and implementing process improvement initiatives for sponsors, CROs and clinical sites.

She is an experienced auditor and has expertise in SOP development for both investigator and sponsor organizations. She has experience in Pre Approval Inspection readiness and has assisted organizations in developing and executing Corrective Action Preventative Action Plans in response to both regulatory inspections and sponsor audits. She has led the implementation of eSource systems in Phase I and has expertise in the clinical validation of these systems.