Dr. Rene Kozloff has more than 30 years’ experience in overseeing the design, implementation, operations, and analysis of clinical studies. She is actively involved in protocol development, subject recruitment and retention strategies, and clinical site staff training. She is expert in good clinical practices and trains sites on its implementation.
Dr. Kozloff provides regulatory oversight and ensures the safety of study participants. She has taken an active part in the issues associated with confidentiality and privacy and has expertise in the special protections for children, the mentally ill and substance abusers. She collaborates with the data management and statistical teams to insure the inclusion of clinical considerations in design and implementation of studies and analyses and writes clinical trials study reports for submission to the Food and Drug Administration.
Dr. Kozloff is an expert in defining and validating multidisciplinary outcome measures. She has experience in managing both the National Institutes of Health (NIH) and biopharmaceutical research programs and interacts with clients, internal staff, consultants, contractors, and vendors. She has designed and managed pediatric phase I and IV studies and provided technical, writing, and regulatory support to studies.
Dr. Kozloff has applied her skills to the design, implementation, and management of studies for the NIH National Institute of Child Health and Human Development’s Pediatrics Pharmacology Research Units, NIH National Institute on Drug Abuse clinical and data management projects, and NIH National Institute of Mental Health and National Center for Complementary and Alternative Medicine studies. In addition, she supports the biopharmaceutical industry in its clinical study activities in a broad range of therapeutic areas, with particular expertise in the neurosciences, pain, suicide, mental health, and substance abuse.
In addition to leading KAI Research, Inc. clinical activities, Dr. Kozloff has provided support to projects and trained investigators and staff in identifying, recruiting and retaining minorities, children, and marginal populations to studies.
Dr. Kozloff holds both a doctorate of philosophy in medical anthropology and a master’s of arts in anthropology from the Catholic University of America College of Arts and Sciences. She also holds a bachelor’s of science in nursing from the University of Pennsylvania School of Nursing.
Her areas of expertise include clinical data management; clinical studies support; clinical safety and pharmacovigilance; and recruitment and retention of clinical studies with an emphasis on minority, pediatric, and hard-to-reach populations.