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Description
The course supplies learners with an understanding of the steps needed to establish a new clinical research program, including how to set up a clinical research site, assemble a research team, build a clinical trial portfolio, and adhere to best practices in clinical trial documentation and data management. The course provides recommendations on how to work with sponsors, contract research organizations (CROs), and study monitors. It also details best practices for working with Institutional Review Boards (IRBs), oversight committees, and the U.S. Food and Drug Administration (FDA).
Audience
Clinicians, Faculty, Institutional Officials, Principal Investigators, Research Administrators
Meet the Authors
Ximena Levy, MD, MPH, PhD(c) – Baptist Health South
Ximena Levy, MD, MPH, PhD(c), is a physician–scientist and research executive with over 20 years of experience in translational research, regulatory compliance, and clinical trials. She currently serves as Director of Research Operations at Lynn Cancer Institute, advancing ethical, efficient, and collaborative clinical research.
Karin Scarpinato, PhD – Kennesaw State University
Dr. Karin Scarpinato is a dedicated leader in higher education, research, and innovation. As Executive Vice President for Research at Kennesaw State University (KSU), she oversees the university’s research programs, working to expand opportunities for faculty and students, attract funding, and foster collaborations that drive discovery and innovation.
Laura Liranzo, MD – Headlands Research
Laura grew up in the Dominican Republic, earned her medical degree, and began validated her credentials to train in the United States. While studying for her board exams, she discovered a passion for research through coordinating vaccine, metabolic, and neurodegenerative trials, shaping her goal of becoming a specialist and Principal Investigator.
Nicholas Toll, MS – JEM Research Institute
Nicholas is a medical student at the Lake Erie College of Osteopathic Medicine with bachelor’s and master’s degrees in Biomedical Sciences. His research experience includes COVID-19 biorepository development, early Alzheimer’s disease markers, and studies at JEM Research Institute involving neurological disorders, COVID-19 vaccines, and GLP-1 receptor agonists.
Santiago Vanegas Rincon – Headlands Research
Originally from Colombia, Santiago is a clinical research professional with years of experience spanning biocollection management, vaccine development studies, and complex neurology trials. He is currently contributing to high‑enrolling neurodegenerative research and bringing strong operational expertise to the conduct of demanding, detail‑intensive clinical studies.
