Kaushal Shah, PhD
Director & Clinical Associate Professor, Clinical Research Management & Regulatory Science Programs
Arizona State University
Dr. Kaushal Shah is an Associate Professor and Director of the Clinical Research Management and Regulatory Science Programs at Arizona State University, with over two decades of experience spanning clinical operations, trial oversight, and regulatory compliance. Her industry background includes leading clinical trials and managing regulatory submissions for pharmaceutical drugs, biologics, and novel therapeutics across global markets. Dr. Shah has educated professionals on good clinical practice, protocol adherence, and quality systems, and currently teaches advanced courses on medical device regulation and clinical research operations. She serves as President of the ACRP Phoenix Chapter and is an invited contributor to national conversations on regulatory agility and workforce readiness. Her expertise in risk-based trial management and FDA regulatory expectations directly informs her session on identifying and reporting important protocol deviations in alignment with the FDA’s 2024 draft guidance. Her work bridges practice and education to strengthen protocol compliance and operational excellence.