Karen Ivinson serves as a program officer within the Clinical Unit. She acts as the Clinical Operations Lead and/or Project Manager for various MVI projects with Phase 1/2 clinical trials. Her responsibilities include serving as the clinical operations interface with external partners, conducting site assessment visits, conducting and coordinating protocol reviews, preparing and managing submissions to ethical review boards, and monitoring and overseeing clinical trials being conducted in Africa, the UK, Australia, and the U.S.. Karen also works on the RTS,S Phase 4 pharmacovigilance study and was involved in the earlier Phase 2 and 3 trials of RTS,S.
Karen has more than 14 years of experience working in clinical research and development. She joined MVI from the Meningitis Vaccine Project at PATH, where she was responsible for the management and coordination of a Phase 3 infant clinical study in Ghana. She has a background in infectious diseases, immunology and vaccine research, and in preclinical therapeutic vaccine development. Prior to joining PATH, Karen worked on many international, multi-center Phase 2/3 studies in Australia and the United Kingdom (that involved HIV and other infectious diseases, pediatric vaccine, renal, and neurological studies).
Karen received her BSc and BSc (Hons) in microbiology and immunology from the University of Melbourne in Australia. She is based at PATH's offices in Geneva, Switzerland.