- South Africa
- Hong Kong
- New Zealand
- Czech Republic
- United Kingdom
Head of Clinical Operations
Clinical Study Operations, Global Research and Development
Base/Location: New London, Connecticut, USA (home office – Anderson, South Carolina, USA)
NGO Partner: International AIDS Vaccine Initiative (IAVI)
Assignment Location: Nairobi, Kenya
Duration: August 2010 – January 2011
Fellowship Title: Science Writer Fellow
Randy has worked for legacy Pfizer for over 26 years in several different positions starting with the Path/Tox Department conducting animal safety studies. After three years he changed career paths to work as a Science/Medical Writer supporting preclinical and clinical studies and publications in various indications, as well as preparing sections of regulatory submissions. He then shifted into Clinical Development in 1996 as a Clinical Research Manager conducting clinical studies in infectious disease and urology before accepting a secondment in Japan as Director of Clinical Operations in 2001 with Pharmacia. He joined Pfizer while in Japan in and eventually moved back to the US to settle in Ann Arbor, Michigan, as a Clinical Program Operations Manager primarily with responsibilities for studies in women's sexual health. In 2006 Randy joined Clinical Study Operations and has been brokering studies as the Head of Clinical Operations in Pain, Allergy & Respiratory, Genitourinary, and Gastrointestinal Disease Areas since then.
While earning his Masters Degree in Veterinary Science, Randy's research was focused on the epizootiology of bovine leukemia virus, which is a retrovirus like HIV. On his assignment with IAVI, Randy will be working with principal investigators and their staff at Clinical Research Centers in Kenya to ensure timely and accurate publications based on IAVI–sponsored research. In addition, he will work with the IAVI team in Nairobi to increase output of publications by helping to identify other potential publications from data accumulated from epidemiologic work conducted to date and assisting in the editorial process. Randy plans to conduct workshops to help build capacity of the IAVI staff and partners as necessary. From the experience Randy hopes to gain a better understanding of HIV/AIDS research and the challenges of developing a vaccine. Randy expects to bring back a better understanding of what it takes to conduct clinical research and observational studies in another part of the world and use insights gained to influence his work going forward.
IAVI is a global nonprofit, public–private partnership working to ensure the development of safe, effective, and accessible HIV vaccines.
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