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Dr. Kunitz has over 30 years of proven ability in applying innovative methodology, technology, and organizational structures to clinical studies. She has successfully led and collaborated with multidisciplinary teams of statisticians, epidemiologists, clinical investigators, and programming staff to conduct large multi-center clinical studies. She provides project oversight for research design, implementation, data management, safety monitoring, statistical methodology, and quality assurance.
Dr. Kunitz currently serves as Project Director for several ongoing NIH contracts and in this role leads KAI efforts to develop quality assurance guidelines, checklists for investigator conduct of clinical trials, data and safety monitoring boards (DSMBs) and procedures, common data elements and data warehouses. She has provided QA assistance, consultation, and assessments for over 50 clinical studies conducted at academic institutions throughout the U.S. She has been a recognized leader in developing and implementing state-of-the-art clinical data management systems (CDMS) and has given presentations and lectures for pharmaceutical trade associations including the Drug Information Association (DIA), Society for Clinical Data Management (SCDM) and Society for Clinical Trials (SCT). Dr. Kunitz is also experienced in development of outcome and life quality measures, clinical software, and health systems.
She has a B.A., in Economics from the University of Rochester, an M.S., in Management Information Systems and Organization Development from American University and a Ph.D., in Public Health (Behavioral Science/Social Epidemiology) from Johns Hopkins University.
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