The instructors who teach in the University of Chicago Graham School Clinical Trials Management and Regulatory Compliance Certificate come from labs and organizations throughout the medical trials process. They have developed and tested pharmaceuticals, medical devices, and other therapies that have been launched globally. Their diverse experience makes them both excellent instructors and career coaches for students entering the medical testing field. Their practical experience translates into clinical trials management instruction that prepares our learners to enter a growing field that demands skilled employees who will excel in a highly controlled and regulated work environment.
Our instructor’s professional roles have ranged from managing the finances and administrative responsibilities of organizations conducting clinical trials to developing, executing, and reporting on and presenting trial results. Their exposure to and experience with every phase of the clinical trials process helps our learners map their own careers in this complex and ever-evolving industry.
Melissa is Director of Research Operations and Conduct for the Office of Clinical Research at the University of Chicago Medicine. Melissa has ten years of experience in research operations and oversight, including financial and administrative management, regulatory compliance, research workforce development, and compliance program enhancement. Melissa brings both industry and an academic research perspective to her work and her areas of expertise include FDA law, ICH Good Clinical Practice, medical device research, biomedical ethics, quality assurance auditing, and research process improvement analysis. Melissa obtained a master’s degree in Medical Ethics and Health Policy from the Perelman School of Medicine at the University of Pennsylvania.
Clarice has over 13 years of experience in new medical product development and has been working in project and program management for major medical device companies, in multiple therapeutic areas, for nearly 10 years. Clarice has extensive experience in all aspects of clinical strategy and clinical project development including execution, close-out, and presentation of results in both pre- and post-approval studies in multiple geographies.
Eileen has been a clinical trials project manager for over 10 years, managing the financial and administrative processes for industry-sponsored, federally-sponsored, and investigator-initiated clinical research trials. Before becoming involved in the clinical side of research, she worked in preclinical development focusing on the molecular etiology of congenital heart abnormalities. She received her Ph.D. in Nutritional Sciences from the University of Wisconsin-Madison.
Martin is director of statistics at AbbVie and has over 15 years of experience in pharmaceutical research and development, primarily for treatments of HIV infection and Hepatitis C virus infection. He earned his PhD in Statistics at the University of North Carolina at Chapel Hill.
Andrew has over 20 years of cross-functional project management experience in drug development. As a global operations manager, he has been responsible for NDA filings in the US, Europe, and Japan. Dr. Kucharski is experienced in both clinical and medical affairs and has leveraged global teams from first-in-human trials through product launch and life-cycle management. He possesses a strong interest in pharmaco-epidemiology, pharmacovigilance, and safety signal detection. He has assumed leadership roles in developing strong alliance partnerships, designed and implemented global quality oversight programs and has significant experience in FDA mandated risk evaluation and mitigation strategies. Dr. Kucharski is a sought after presenter at scientific meetings, a published author whose work appears in high impact peer review journals, and has been a guest speaker at U.S. FDA. A trained innovation and change management coach, Dr. Kucharski’s personal mission is to foster talent and mentor individual development. He holds a PhD in Epidemiology focusing on serum secosteroid levels as a risk factor for health disparities.
Pamela is an experienced quality manager, auditor, course developer, instructor, and consultant who brings with her over 16 years of experience in the areas of clinical research, compliance, auditing, training, and quality assurance. Pam is also both an ASQ Certified Quality Auditor as well as an ASQ Certified Quality Manager. Pam is currently VP of Mason Professional Services, LLC and an Adjunct Faculty member for Northwestern University’s Masters Program in Quality Assurance and Regulatory Science.
Melvin is currently a Director in the Safety Statistics and Risk-Based Analytics Group within the Data Science Institute at Takeda Development Center Americas, Inc. in Deerfield, Illinois. He received his PhD in Mathematical Statistics from Queen's University in Canada and also holds an MSc in Mathematical Statistics and MEd in Mathematics, both from McGill University in Canada. He has been in the pharmaceutical industry for more than 20 years and has participated in several global drug submissions. He is also involved in some initiatives of the Drug Information Association Bayesian Scientific Work Group and the American Statistical Association of the Biopharmaceutical Section. He has been the Publicity Chair of Midwest Biopharmaceutical Statistical Workshop since 2005. He has also held positions of President, Program Chair, and Chapter Representative of the Northeast Illinois Chapter of the American Statistical Association.
Sheri has over 25 years of clinical trial experience in the pharmaceutical and medical device industry. Sheri currently serves as president of Courante Oncology, a specialty consulting company that provides customized clinical research consulting and services to companies that are developing new products for the treatment of patients with cancer. Her previous positions include clinical operations, project management, clinical research associate and clinical statistician so she brings a broad range of experience in the conduct/execution of clinical trials, as well as the associated data collection and analysis. She has been intricately involved with numerous IND/NDA/PMA submissions and has been a clinical reviewer on product due diligence teams for multiple companies. Sheri has an undergraduate degree in biology and a Master’s degree in statistics.
Lauren has over 10 years of experience in Hematology/Oncology clinical research operations spanning industry and academic healthcare. Lauren currently oversees the clinical research operations in the section of Hematology Oncology at the University of Chicago. Her primary responsibilities include planning, organizing, directing, and overseeing daily clinical research operations for over 300+ clinical trials. Prior to taking her role in the academic setting, Lauren worked at an Oncology CRO where she gained experience in clinical trial monitoring and project management. In addition, Lauren traveled to several NCI designated cancer centers to conduct site visit audits. Lauren holds an MSc degree in Clinical Research Administration from the George Washington University. Lauren has a strong passion for teaching and mentoring others about the exciting career opportunities in the field of clinical research.
Dr. Yeo is the Associate Director of Investigator Services at the Office of Clinical Research at the University of Chicago Medicine. Dr. Yeo has over 20 years of experience as a research scientist working on various preclinical and clinical research projects. Four years ago, she transitioned to clinical research administration. Since then Dr. Yeo has been involved in project development and management; in particular, providing guidance, support and training to investigators in developing their clinical study, from study initiation to research conduct and closure. Dr. Yeo received her Ph.D. in Cell Biology from SUNY Downstate Medical Center, Brooklyn, NY and a graduate certificate in Clinical Research & Regulatory Administration from Northwestern University, Chicago, IL.