Christine Pierre, RN, President and CEO, RxTrials, RxTrials Institute and ForeSite Publishing
Christine Pierre has been committed to human subject protection and clinical site operations for more than 20 years. She founded and is president of RxTrials Inc. RxTrials is an elite network of investigative sites that conduct in-patient and out-patient clinical research in a variety of therapeutic areas. RxTrials provides site support services, which include business development, budget and contract negotiation, development of study recruitment plans and execution, education, compliance and auditing, and overall business management of the clinical research site. Recognizing the need for education for the research team, RxTrials through its sister company RxTrials Institute offers training and education through both public and customized courses. In 2006, RxTrials Institute entered into a joint venture with FDAnews to allow for expansion of education to the global research team.
Christine is the immediate past chair of the board of trustees of the Association of Clinical Research Professionals. She has spent nearly two decades as a clinical research professional. She has been the co-principal investigator of a multicenter clinical trial and various single-center trials. Christine frequently lectures, moderates panels and conducts workshops at national and international conferences and is on the editorial board of Clinical Trials Advisor. She co-authored the book Responsible Research: A Coordinators Guide. In 2003, she was nominated as one of the top female business professionals in Maryland.Michael Jay, MA
Martie Griffin, RN, CCRN, MBA
Martie Griffin is the senior director for GCP compliance with The Medicines Company. She has more than 16 years of experience in the pharmaceutical industry, mostly in a compliance role, but with wide-ranging experience in disciplines including clinical operations, pharmacovigilance and quality assurance and oversight. Prior to her current role, she was a director of corporate legal regulatory compliance at Pfizer, supporting all GCP aspects of that multinational company. Before entering the pharmaceutical industry, she was a critical care certified RN.
Michael Marcarelli serves as Director, Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health. He currently holds the rank of Captain in the US Public Health Service Commissioned Corps. He has 19 years of FDA regulatory experience in the premarket and postmarket oversight of drugs and medical devices. He has held senior FDA positions in operations, compliance, and policy in the District Offices and Headquarters. Prior to his work at FDA, he served as an Investigator with the Drug Enforcement Administration and as a clinical pharmacist with the Veterans Administration.
Deborah Rosenfelder, RN, BSN, CCRC
Deborah Rosenfelder is a lead research coordinator in cardiology at the University of Pittsburgh Medical Center. She has over 15 years of experience in clinical research in the drug and device arena at the University of Pittsburgh Medical Center. As a lead coordinator, she provides guidance on process, coding, billing and reimbursement issues related to research. She is a certified clinical research coordinator and is active in ACRP, having served on various boards and as treasurer of the local chapter. She is also the past president of the local chapter. Additionally, she lectures on a variety of subjects, including cardiovascular disease, device trials and reimbursement issues.
Michael Sanchez, MA, CCA
Mike Sanchez is the principal reimbursement analyst responsible for the Clinical Trials Reimbursement Program at Boston Scientific’s Cardiac Rhythm Management (CRM) business in St. Paul, Minn. He has 14 years of experience in healthcare, including over 10 years within the cardiac medical device industry with five years specifically in clinical trial reimbursement policy. His area of expertise includes Medicare requirements for appropriate coverage, coding and payment of Category-B investigational device exemptions and best practices for clinical trial budgets and contracting using third-party payer rules and financial benchmarks. Since 2001, he has implemented reimbursement strategies and delivered center training presentations for over 40 investigational device studies including the landmark trials of MADIT-II, MADIT-CRT and COMPANION.
Lee Truax-Bellows, MS, RN, FNP, CCRA
Lee Truax-Bellows is a founder, the president and the CEO of Norwich Clinical Research Associates Ltd. She has been involved in regulated research for the past 17 years and specializes in product development, GCP auditing and training on U.S. regulated research and good clinical practice. She is a family nurse practitioner with an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO. She sits on ACRPs Medical Device Forum Steering Committee and is president for the ACRP Central New York chapter. She is an ACRP certified clinical research associate. She is also a member of the DIA, SoCRA and SQA.
Deborah Rosenbaum, CCRA, CCRC
Deborah Rosenbaum is the lead consultant for Sarrison Clinical Research and has over 30 years experience in research. She is certified by ACRP as a CRA and a CRC. Her experience includes conducting preclinical research as a clinical research scientist for industry and a clinical research coordinator.
She is the coauthor of a series of 3 books on clinical research entitled “The Practical Clinical Trial Series.” As a member of the GCP Support section at Burroughs Wellcome, she was responsible for development, revision, and implementation of Wellcome Clinical Research training programs, as well as development of international standard operating procedures.
She participated in the development of the ACRP CRC Certification Preparation course (1995-1996) and was a reviewer of the ACRP CRA Certification Preparation course (1996-1997).
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