 |  Partner, Clinical Operations | Clinical Implementation Director Grants and Contracts | Regulatory Excellence Through Experience |
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Nancy C.G. Snowden, RN, CCRA, Founder and President, NCGS and Associates, Inc. Nancy founded NCGS, in 1984 and brings over 20 years of diversified medical and business experience to the helm. Previous to the inception of NCGS, Nancy served in critical roles as a Senior Research Coordinator, an Oncology Clinical Research Coordinator and as a MICU Surgical Charge Nurse. Her clinical trial experience includes oncology, HIV / AIDS, AIDS related disorders, transplant medicine, infectious disease, women’s health, wound healing and novel diagnostic products in infectious disease. Nancy is a recognized advisor and public speaker on clinical research and trial management, performance metrics, HIV treatment, Infectious Disease treatment, Sepsis treatment, cancer therapies, oncology patient care, and cancer nutrition. Nancy has a Registered Nursing Degree and continues to expand her knowledge base by attending educational seminars in research methodologies, business management, data management, and statistical analysis. | |
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James C. Allen, MD, Medical Director. James C. Allen, MD received his baccalaureate degree from Harvard University and completed his medical education and residency training in Internal Medicine at Johns Hopkins University School of Medicine. He received fellowships in lipid metabolism, infectious disease and immunology at the National Institutes of Health, Johns Hopkins and the Rockefeller University. Dr. Allen held faculty positions in Infectious Diseases at Johns Hopkins and as Director of the Division of Infectious Diseases at the State University of New York Buffalo School of Medicine. He was professor of Medicine and Deputy Director of the Department of Medicine at the University of Maryland in Baltimore and then Professor and Chairman of the Department of Medicine at the Medical University of South Carolina. He is currently an Emeritus Professor at that University. He served as Vice President of Medical Affairs at Roper Hospital in Charleston from which he retired in 1995. He then joined NCGS and served as Medical Director for infectious disease and oncology trials for several years. He has recently rejoined the NCGS Clinical Development Team to serve as Medical Director for all ongoing trials.
Dr. Allen is the author of three books and of scientific articles in the disciplines of immunology and infectious diseases published in a number of national and international medical journals, including the Journal of Clinical Investigation, the Journal of Experimental Medicine, Science, Nature, the Journal of Immunology, and the Annals of Internal Medicine. He is certified by the American Board of Internal Medicine, was elected as a Fellow of the American College of Physicians and of the Infectious Diseases Society of America. He is a past President of the American Clinical and Climatological Association. He has been elected to Phi Beta Kappa and Alpha Omega Alpha. He is the recipient of the Sandoz Award for Medical Scholarship, the Lederle Medical Faculty Award, a Research Career Development Award from the National Institutes of Health, and an award as Outstanding Attending Physician in Medicine from the State University of New York School of Medicine. He has been elected to membership in the Johns Hopkins University Society of Scholars. NCGS is pleased to provide such a distinguished Medical Director in support of our Core Clinical Development Team.
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Janice Durden, BS, MBA, CCRA. Janice holds a Bachelor of Science Degree in Microbiology from Clemson University and a Masters in Business from the Citadel. Janice has experience in both clinical and diagnostic trials beginning her career in 1996 at Organon Teknika and joining NCGS initially in 1997 focusing on infectious disease trials. She returned to NCGS in 2003 as Manager of Clinical Operations and Implementation. Clinical focuses include: oncology; infectious disease, neuro-psych, women’s health and QT prolongation trials. Currently Janice is the Sr. Director of Clinical Implementation and heads a pivotal rapid deployment team that plays a role in launching key studies or takeover of ongoing trials that require additional staffing for timely completion. | |
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Ann Stone, MSN. Ann is a master prepared nurse with 12
years of clinical industry experience functioning as a CRA, Sr. CRA, PM
and Director. Her clinical expertise includes infectious disease
(sepsis, CAP and HAP), pulmonary medicine (CAP/HAP) and neuropsychology,
etc. She has also managed pediatric, adult, and device trials. | |
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Paulette MacDougall, RN, BSN, CCRA. Paulette earned
a Bachelor of Science degree in Nursing from Eastern Michigan University
and successfully obtained licensure as a Registered Nurse in the spring
of 1995 and brings nearly 15 years of nursing, clinical, research and
regulatory experience to NCGS. Paulette entered her nursing career as an R.N. in a variety of therapeutic hospital settings including dermatology, surgical oncology, plastic surgery, general surgery, renal and diabetes units. She entered the realm of clinical research in 1997 at Duke University where she worked as a Clinical Research Coordinator and eventually became the Clinical Research Manager for the Duke HIV/AIDS trial unit which conducted numerous NIH and pharmaceutically-sponsored clinical trials. During this time Paulette played an active and visible role in a local patient-run HIV/AIDS Community Advisory group, volunteered for a variety of patient-focused subcommittees under the NIH AIDS Clinical Trials Group (ACTG) and was eventually elected to membership in the national ACTG Patient Care Committee. Paulette left academia to expand her regulatory experience in 2001 when she began working independently in the North Carolina Research Triangle Park (RTP). During this time Paulette accepted a variety of short-term contracts including regulatory positions for a number of Clinical Research Organizations and Pharmaceutical Sponsors including site recruitment, study start-up, remote study management and in-house Clinical Research Associate. Her work in RTP ended with a contract-to-permanent regulatory position on a study team for HIV/AIDS Clinical Operations at GlaxoSmithKline. In 2003 Paulette relocated to Charleston where she accepted a position as the Research Program Manager for the Digestive Disease Center at the Medical University of South Carolina and assumed responsibility for project management, grant and protocol-writing as well as regulatory oversight and training for Phase I-IV diagnostic, therapeutic and/or device trials in gastroenterology. During this time Paulette also obtained certification as a Clinical Research Coordinator (CCRC) in 2004 and was an instrumental founding member of the Low Country Chapter of the Association of Clinical Research Professionals (LCACRP) where she functioned as an elected LCACRP officer from 2004-2007. In November 2008 Paulette joined NCGS as a Regulatory Consultant where she continues to focus on the conduct of clinical trials and related processes to ensure continued compliance with ICH, GCP and FDA requirements as well as her continued advocacy for the rights and protection of human subjects in research. She is currently a member of the ACRP, Regulatory Affairs Professional Society (RAPS) and the American Medical Writers Association. | |
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Lakashia Johnson Rhodes. Lakashia Johnson holds a Baculaureate Degree in Business and Accounting from the College of Charleston. She joined NCGS in 1995 and served as Manager of Business and Grants until 2003. In that capacity she negotiated and managed site budgets, executed CDAs, negotiated site contract language on behalf of our sponsors and tracked and evaluated grant/site expenditures providing performance metric reports. She served as a paralegal in two local law firms and rejoined NCGS in 2006 as Senior Manager of Grants and Contracts
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