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.
Sharon Benoit, RN, BSN, MPH
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.