Mrs. Hongxia Li has a broad education background in Medicine, Epidemiology (track of Clinical Research), and Information Systems. She graduated from China Medical University in 1995; she completed the first master’s degree in Information System in 2002 at University of Maryland Baltimore County (UMBC) and the second master’s degree in Epidemiology (with track of Clinical Research) in 2009 at University of Maryland School of Medicine.
Mrs. Li has over 8 years of working experience in clinical research, including study initiation, subject screening and recruitment, Institutional Review Board submission, regulatory document management, data quality control, etc. of observational studies and Phase I/II/III clinical trials. She is currently a senior research program coordinator at Division of Pediatric Gastroenterology and Nutrition, The Johns Hopkins University School of Medicine. Mrs. Li has not only in-depth knowledge on the principles and concepts of clinical research and human research subject protection, but also hands-on industry working experience on quality management of clinical trials, including performing protocol risk assessment, providing consultancy to project operation team, performing Root Cause Analysis (RCA) on occurred quality issues, and identifying Corrective and Preventive Actions (CAPA) to address these issues. Mrs. Li is currently a member of Society of Clinical Research Associates (SoCRA).