Contact Information
| Address: Office of Clinical Research 218 West Fee Hall Michigan State University East Lansing, MI 48824 E-mail: clinicalresearch@hc.msu.edu Phone: 517-432-5479 Fax: 5170-432-5491
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 Photo: UtopianDreaming |
Staff BiosSharon Schooley, BS, is OCR’s Clinical Research Operations Specialist, with over 20 years experience in both bench and clinical research. She has served in such roles as laboratory manager, research microbiologist, and senior research coordinator. She is a published researcher, and has been involved with project development and protocol design for investigator-initiated studies, budget development and negotiation, and clinical research and trial management for primarily industrial and some federally-sponsored projects. She works with researchers to facilitate assistance with regulatory documentation, study budget development and justification, and budget negotiation, and acts as a liaison between regulatory departments to determine areas of need and solutions to best fulfill them. She has extensive knowledge and experience in multiple areas of clinical research, including acting as a liaison between research investigators and sponsors, project feasibility assessment, research agreement negotiation (confidentiality agreements, material transfer agreements, clinical trial agreements), and creation and processing of IRB regulatory documentation. She works one-on-one with individual investigators to facilitate their request for regulatory or budgetary assistance, with the result of a decrease in processing time, and increased efficiencies and research compliance through education of researchers. Sharon is currently involved with multiple research committees on campus and has been an active member of the Society of Research Administrators (SRA) since 2006, and of the Association of Clinical Research Professionals (ACRP) since 2007. Ann Smith, BA, is the Research Administrator for OCR, and the Clinical Research Operations Administrator for CTSI. Ann has been at MSU for over 21 years and brings extensive experience in Research Administration, including 13 years within the College of Human Medicine, an academic medical setting. During the last 10 years, Ann has specialized in Clinical Research, having been involved in the development of clinical trials/clinical research infrastructure, and has completed certifications in clinical trials administration & clinical research skills workshops development. She brings expert operations experience in unit start-ups having served as the founding departmental administrator/research administrator for the Center for Microbial Ecology (89-94); Department of Epidemiology (94-03), Interim Administrator for the Breast Cancer and the Environment Research Center (03-04) and division administrator for the Division of Dermatology (07-08). Ann also worked on the development of the new Enterprise Business System Project /Kuali Financial System & Kuali Research Administration, serving as co-team lead on the Grants & Contracts Team from (05-06) and continues to serve as a subject matter expert. Other research administration skills include an understanding of contract development and negotiation, budget and budget justification preparation, regulatory compliance, standard operating procedure (SOP) development, and a understanding of ensuring that Good Clinical Practices (GCP) guidelines as part of clinical research. She also assists investigators in identification of funding sources, serves as a liaison with multiple units including Contract and Grant administration, and works with others on providing information regarding interpretation of funding sources, federal/state and MSU guidelines. Ann has been an active member of NCURA since 2003 and an active member of SRA since 1994, and is part of the NCURA Leadership Development Institute Class of 2008.
Loren Friedman, MS, has recently joined OCR as the Director of Clinical Trials. Previously, Mr. Friedman was the Director of Clinical Trials at the University of Cincinnati in both the Psychiatry Department and at the University level plus an Associate Professor of Psychiatry (Research) at the University of Cincinnati. With special expertise in drug development and clinical trials management, he has over 25 years of extensive experience in all aspects of the development and maintenance of clinical trials. In Cincinnati, he directed over 600 clinical trials during the 17-year course of the program and participated in many clinical translational projects. He was the Principal Investigator on the Regulatory Cores of both the National Institute on Drug Abuse (NIDA), Cincinnati VA Medications Development Unit, and the NIDA-funded Strategic Program for Innovative Research on Cocaine Addiction Pharmacotherapy (SPIRCAP) project, involving the development of an antibody treatment for cocaine addiction from synthesis in the laboratory to Phase II clinical trials in humans. He has served on the University of Cincinnati IRB in the capacity of a primary psychiatry reviewer, and as IRB liaison with the Department of Psychiatry. He currently serves as a member of the MSU IRB.
Gary E. Stein, PharmD, Research Consultant, is a Professor of Medicine and Pharmacology in the College of Human Medicine, Department of Medicine, Division of Infectious Diseases. With over 25 years of clinical research experience, Dr. Stein has been involved in both clinical trials and investigator-initiated research, coordinating funding from both Federal and Industry sources. Dr. Stein has had a mentoring role in equipping new researchers for pursuit of clinical research projects, and will devote time as needed to facilitate mentoring and training of new investigators. |
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