Timothy Rapuano
Research Coordinator
Bio:
Timothy Rapuano is a project management and regulatory affairs leader with over 20 years of experience advancing clinical research and quality initiatives across academic, public health, and industry settings. He currently serves as Project Coordinator in the Division of Allergy & Infectious Disease at University of Washington Medicine, where he manages multi-site, CDC-funded studies focused on syphilis prevention and the implementation of point-of-care testing across six U.S. jurisdictions.
A skilled strategist in regulatory compliance and clinical trial operations, Timothy’s expertise spans FDA, ICH, GCP, GLP, and GCLP frameworks. Prior to his role in academia, he led global quality assurance initiatives at Pfizer’s Vaccine Research and Development division, where he directed laboratory compliance programs and implemented 21 CFR Part 11-compliant systems to streamline regulated research processes.
Timothy holds a Master of Science in Quality Assurance and Regulatory Affairs from Temple University and is a certified Project Management Professional (PMP). His additional training includes credentials in Agile methodology, clinical trial management, and Six Sigma, equipping him with a versatile toolkit to support cross-functional teams and drive operational efficiency.
Beyond his professional work, Timothy serves as President of the Organization of Regulatory and Clinical Associates (ORCA), a Seattle-based nonprofit committed to professional development in the regulatory and clinical space. He is also the founder of The Research Reboot, an initiative designed to help career changers successfully transition into clinical research roles.
His work has been published in peer-reviewed journals and featured in Global Health NOW, with recent advocacy focused on elevating awareness of neglected tropical diseases such as Cryptosporidiosis. As a speaker, Timothy covers topics including regulatory innovation, quality systems design, cross-functional leadership, and the evolving impact of generative AI on clinical trial workflows.