Meet The Team

Rene Kozloff, PhD

Founder, KAI Research, Inc.; Senior Clinical Research Scientist

Rene Kozloff portraitRene 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 an 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 ensure the inclusion of clinical considerations in design and implementation of studies and analyses, and she writes clinical 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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA) clinical and data management projects, and studies for the National Institute of Mental Health (NIMH) and the National Center for Complementary and Alternative Medicine (NCCAM) . 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 clinical activities, Dr. Kozloff has 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 of arts degree in anthropology from the Catholic University of America College of Arts and Sciences. She also holds a bachelor of science degree in nursing from the University of Pennsylvania School of Nursing.

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