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 Colleen O. Lee, MS, AOCN ®, APRN-BC ®

Senior Regulatory Scientist
National Children’s Study 

CDR Colleen Lee is a nurse practitioner and clinical nurse specialist currently on detail from the National Cancer Institute’s (NCI) Office of Cancer Complementary and Alternative Medicine (OCCAM). She recently joined the National Children’s Study in the role of Senior Regulatory Scientist, focusing on the approval of Vanguard and Main Study components through the Office of Information and Regulatory Affairs within the Office of Management and Budget.

CDR Lee joined NCI’s OCCAM in 2001 and managed the daily activities of the NCI Best Case Series Program. In this role, she reviewed over 500 case studies involving the use of alternative therapies for the treatment of cancer in adults and children to determine if there was sufficient evidence to warrant NCI-initiated research. She gained her oncology experience as a clinical research nurse at the University of Pennsylvania and the NIH Clinical Center in the inpatient medical oncology units. Before coming to OCCAM, CDR Lee served as the clinic coordinator and senior transplant coordinator for the National Institute of Diabetes and Digestive and Kidney Diseases Solid Organ Transplant Program. She is an Adjunct Medical Staff member at the NIH Clinical Center in the Center for Cancer Research, Medical Oncology Branch, previously seeing clinical trial patients in the prostate, bladder, mesothelioma, and multiple myeloma clinics and day hospital. CDR Lee is the former coordinator of the Oncology Nursing Society’s (ONS) complementary and integrative therapies special interest group through which she developed and delivered workshops, Web courses, and publications as a part of special team projects with ONS.  

CDR Lee received her
Bachelor of Science in nursing from St. Mary’s College in Notre Dame, Indiana. She received her Master of Science in advanced practice oncology nursing (clinical nurse specialist) and completed her primary care nurse practitioner certification at the University of Maryland. She also recently completed her training as a certified legal nurse consultant. CDR Lee converted to the U.S. Public Health Service (USPHS) following 14 years of civil service and currently serves as Medical Branch Director for the USPHS Rapid Deployment Force Team 1 located in the Washington, DC area.