Performance, Excellence, & Efficiency in Research
George Gasparis is the President of The PEER Consulting Group, LLC. With over 30 years of experience in the conduct, administration, review, and compliance oversight of research, he provides expert consultation for human research protection programs, IRBs, and principal investigators/research teams. Before starting the consulting company, he served as the Asst. Vice President and Sr. Asst. Dean for Research Ethics at Columbia University from 2003 to 2012. In this capacity, he served as the Executive Director of the Human Research Protection Program/IRB for Columbia University, Columbia University Medical Center (CUMC), and New York Presbyterian Hospital at CUMC. The Columbia IRB Office managed six IRBs that provided oversight for over 4,500 total active protocols and over 1,500 new protocols per year. The office also enhanced regulatory compliance through its Compliance Oversight Team and promoted educational training for researchers through comprehensive training programs. He directed and reviewed over 600 compliance oversight investigations.
Prior to his arrival at Columbia University in June 2003, George was the Director for the Division of Assurances and Quality Improvement at the Office for Human Research Protections (OHRP). After the initial design of the FWA by Dr. Tom Puglisi at OHRP, George was instrumental in obtaining agreement of the Terms of Assurance by the 16 federal departments and obtaining approval of the FWA by the Office of Management and Budget (OMB). He also simplified the submission and approval process for the FWA by implementing an electronic submission system for the FWA. Under the leadership and direction of Dr. Greg Koski and the assistance of Yvonne Higgins, he developed and implemented Dr. Koski's vision and idea of a Quality Improvement (QI) Program. Under George's leadership, the Division conducted about 30 QI evaluations of large and small institutions, including five institutions in South Africa. The instituions included some of the most prominent academic medical centers in the U.S., community hospitals, and liberal arts universities.
Prior to his tenure at OPRR/OHRP (from 1996-2003), he was the Director, Office of Human Research at The George Washington University Medical Center (GWUMC) from 1991 –1996. In that capacity he served as the administrator for the GWU Medical Center IRB, Director of the Research Pharmacy, and also served on the behavioral IRB for the university. George also gained extensive experience with clinical trials when he was employed at the GWU Lipid Research Clinic (LRC) from 1981-1991. During his tenure as Data Manager at the LRC, he managed over 40 clinical trials, including NIH awards and studies for 10 different sponsors. He is a graduate of GWU. George became a Certified IRB Professional in 2003.
Ms. Naughton has over 16 years of experience in clinical research with a comprehensive working knowledge in cardiology, particularly in interventional cardiology. Shannon gained eight years of industry experience with Boston Scientific where she coordinated and supervised all aspects of implementing and conducting clinical trials in accordance with FDA regulations and GCP/ICH guidelines. She participated in the site selection process, developed monitoring plans, site and sponsor training materials, and study tools. Shannon also managed risk through compliance assessment at both the site and study levels and facilitated problem solving between clinical cross-functional teams. She began her career at Beth Israel as a staff nurse in telemetry and the moved on to the cardiac catheterization lab. Her first exposure to the research field was when she became the clinical coordinator for a newly developed research program. After attending graduate school, Ms. Naughton moved on to become the Director of Interventional Cardiology Nurse Practitioners and Physician Assistants. She then was promoted to Manager of Invasive Services for the Beth Israel Heart Institute. In addition to providing the coordination and oversight of over 5,000 procedures per year, she also chaired the Invasive Cardiology Quality Improvement Committee.
She received her B.S. degree in Nursing at College of Mount St. Vincent and two M.A. degrees in Hospital Administration and Acute Care Nurse Practitioner at New York University.
Ms. Brady has over 20 years of experience in clinical research with a comprehensive working knowledge of all areas of clinical development. Elizabeth is highly accomplished in the selection, negotiation, and management of multiple international contract research organizations. Over the years, she has created RFP’s, drafted budgets, and managed the performance of CROs globally on numerous Phase I to Phase III trials. She has excellent leadership skills in building and managing project teams. Elizabeth has over 15 years of experience in cardiology, oncology, neurology, autoimmune diseases, and devices. Her experience was gained working for Syntex Research (1985-1995), as a Senior Manager at CV Therapeutics (1996-2004), as a Director, Business Development at Charles River Labs (Inveresk) (2004-2006), Director, Clinical Operations at Novacea, Inc., (2006-2007), and as a Senior Manager, Clinical Operations at Genentech, Inc. (2007) and as an independent consultant. At Genentech, Elizabeth managed nine Clinical Trial Managers across four molecular programs: Tarceva, Rituxan, Heme Onc, and Lytics. She has subsequently performed services for Point Biomedical, Inc., GeneEd, Genentech, Inc., and MAP Pharmaceuticals, Inc. Ms. Brady earned her Bachelor of Arts degree at the University of California, Santa Barbara.
Ms. Seymour has over 20 years of experience in research and IRB administration. Patricia has served as the Manager, MetroWest Medical Center IRB in Framingham, MA, Director, Research Administration at MetroWest Medical Center, Director of Site Development/ Operations at Clinical Studies, Ltd. in RI, and the Director Human Subjects Protection Office at Beth Israel Deaconess Medical Center in Boston.
She worked as a Regional Representative and Consultant for Western IRB (WIRB) before becoming their Director, Business Development/Institutions from 2008-2011. Patricia has also served as a Regulatory Analyst and Board Administrator for Quorum Review. During her tenure at WIRB, she served as Interim Director for several major academic medical centers. She has extensive experience in drafting standard operating procedures, reorganization of IRB offices, development and training of managers, staff and board members, and all aspects of IRB review. She has also worked with institutions to facilitate transitions to outsourcing of all or some IRB review to central IRBs.
She received her B.A. degree at Simmons College, attended Boston College for two years to pursue a Masters of Arts degree in American Studies at and earned a Masters of Arts Degree in Health Administration at Framingham State College.
Sharon Benoit has over 25 years of experience in clinical research and pharmaceutical drug development. Having served at ResearchTriangle Institute, Burroughs Wellcome and Glaxo Research Institute , Sharon is also the former President of PharmaResearch Corporation which was founded in 1995 and was acquired in 2003. Under Sharon's leadership , the company gained an excellent reputation for scientific and logistical excellence as well as client and employee satisfaction. While Sharon was the President of PharmaResearch, it was voted Research Triangle Park’s Fasting growing 50 companies 3 years consecutively.
In her capacity as President she oversaw all operations groups including Clinical Research, Biostatistics, Data Management, Business Development and International Operations. In collaboration with a multidisciplinary leadership team revenue grew to approximately $40 million within seven years.
Sharon contributed to the development of multiple novel treatments for HIV/AIDS , hepatitis/malaria and other infectious diseases in collaboration with internationally renowned scientific advisors and clinical investigators.