Karen Ivinson, BSc
Foundation for Appropriate Technology in Health
Karen has over 22 years’ experience working in the field of vaccine and drug research and development – with a particular focus on immunology and vaccine development. Having started in R&D as a Research Assistant in laboratory academic settings, then at a start-up biotech therapeutic vaccine company, Karen then took a position as a Clinical Trials Assistant at a CRO, 17 years ago, and progressed on to Clinical Research Associate and Project Manager roles, monitoring, overseeing and managing clinical trials.
Karen has been with PATH for over 13 years and is a Senior Clinical Program Officer within PATH’s Centre for Vaccine Innovation and Access. She started with the Meningitis Vaccine Project (MVP) and then has worked with the Malaria Vaccine Initiative (MVI) program within PATH for more than 12 years. As such her focus has mostly been on malaria vaccines, and sometimes anti-malarial medications. In her role, she serves as the clinical operations project lead for a number of studies, working closely alongside colleagues and our external partners. Karen’s responsibilities include the identification and assessment of clinical trial sites and CROs; developing and/or reviewing clinical study documents; drafting and negotiating project scope of work and R&R with partners; overseeing, tracking and providing support and input into EC/IRB submissions; maintaining clinical operations timelines, risk management tools, PATH insurance database; reviewing CRO monitoring visit reports and/or site progress reports; overseeing and monitoring the progress of clinical activities.
Karen has worked on many single and multi-centre international clinical trials in malaria, meningitis, polio, HIV and other infectious diseases, paediatric vaccines, renal, and neurological studies. These studies have been in the UK, other European countries, the US, many countries in Africa, Thailand, and Australia, and were conducted in partnership with pharmaceutical, academic institutions and CROs.