Elizabeth Shaffer
Biography
Elizabeth Shaffer, B.S., is a clinical research regulatory expert with more than 15 years of experience supporting large-scale multi-site clinical trials in Alzheimer’s disease research. She currently serves as the Clinical Research Regulatory Manager at the Alzheimer’s Therapeutic Research Institute (ATRI), Keck School of Medicine of USC, where she leads regulatory compliance efforts across studies in the U.S. and Canada.
Elizabeth brings deep expertise in informed consent design, centralized Internal Review Board (IRB) coordination, and regulatory submission strategy, paired with a strong commitment to transparency and participant-centered research. She advocates for the return of research results with informed consent and strives to ensure participants are respected as partners in the research process. Since joining ATRI in 2015, she has led the development of compliant master consent templates, overseen the implementation of the National Institutes of Health (NIH) single IRB mandate, and created regulatory tracking systems to support site readiness and continued regulatory compliance.
She is also an active contributor to national work groups focused on research ethics and participant advocacy, including NIH and Alzheimer’s Clinical Trials Consortium (ACTC) initiatives aimed at improving communication, trust, and equity in clinical trials.
Elizabeth earned her Bachelor of Science in Animal Physiology and Neuroscience with a concentration in Psychology from the University of California, San Diego.
Publications
Podcasts
The Role of Regulatory Affairs in Advancing Alzheimer’s Research with Elizabeth Shaffer
Regulatory affairs is one of the key mechanisms that keeps clinical trials moving forward — ensuring participant consent, overseeing the review process, and helping trials occur faster. In this episode, Elizabeth Shaffer joins the podcast to discuss her work as Regulatory Affairs Manager for the Alzheimer’s Therapeutic Research Institute (ATRI) and the Alzheimer’s Clinical Trials Consortium (ACTC). She shares an overview of the consent process for participants, explains what Institutional Review Boards (IRB) are, and how they oversee research. She discusses some key advancements in the regulatory process for Alzheimer’s clinical trials throughout her career. Elizabeth also reflects on ATRI’s progress and shares some of her hopes for the future of Alzheimer’s research.