ACRP Leadership

2010 Board of Trustees

Officers

CHAIR: Heike Schoen, MSc, MBA, a board member since 2005 and Chair of the ACRP German Chapter, currently works as Managing Director for CSG Clinische Studien Gesellschaft mbH in Berlin. She had earlier been a partner of the consulting company Trockle Unternehmensberatung in Hannover, Germany, and has gained more than 10 years of management experience in other globally operating contract research organizations in Europe. Since joining ACRP in 2001, she has supported chapter activities throughout Germany and co-chaired the Fifth and Sixth Annual ACRP European Conferences.

VICE CHAIR: Valerie Willetts, RN, BSN, CCRA, CCRT, is founder, president, and CEO of ASKA Research in Vancouver, Canada, and has been engaged for more than two decades in managing and monitoring clinical research trials for academia, pharmaceutical and biotech companies, and contract research organizations in North America and Europe. She has served on the ACRP Board of Trustees for the past two years, is a former chair of the ACRP Canada Chapter and a former lead chapter chair for ACRP North America, and delivers a variety of educational programs to the industry.

IMMEDIATE PAST CHAIR: David M. Vulcano, LCSW, MBA, CIP, RAC, is assistant vice president for clinical research with Hospital Corporation of America in Nashville, Tenn., overseeing the research efforts of more than 170 hospitals, 105 surgery centers, various physician practices, and affiliated programs in 31 states, London, and Geneva. He currently also serves as chair of ACRP’s Ethics & Public Policy Committee.

Trustees

Norbert Clemens, MD, PhD, is a board certified physiologist and a member of ACRP’s affiliate, the Academy of Pharmaceutical Physicians and Investigators. His broad exposure to worldwide healthcare issues includes service in several academic positions; as medical director for Intersan GmbH, PAION, and Valeant Pharmaceuticals International; as general manager and head of global clinical trial services at Analytica International GmbH; and as head of clinical development at CRS Mannheim GmbH in Gruenstadt, Germany, his current position. He is a board member of the research and development section of the German Association of the Pharmaceutical Industry, for which he is a member of the drug safety and educational commissions. He also is immediate past president of the German Society of Pharmaceutical Medicine and treasurer of the International Federation of Associations of Pharmaceutical Physicians.

Clara H. Heering, MsC, MsC, is Senior Director Clinical Operations at Quintiles Transnational Belgium, with over 17 years of experience in Clinical Research and the Pharmaceutical Industry. She was formerly director of the Business Innovation Unit with Pfizer Global Research and Development in Belgium. She started with Pfizer in 1992 as CRA and has since gained experience as leader of Clinical Research teams active in Phase I–IV clinical trials in several European countries. She holds degrees in Medical Biology and in Risk Analysis. A former Research Fellow at Harvard Medical School, she also has influenced policy making in clinical research and risk management, and has served as an active board member of the ACRP Belgium Chapter since 2003.

Teresa-Lynn (Terri) Hinkley, RN, BScN, MBA, CCRC, has been an ACRP member since 1997, a Certified Clinical Research Coordinator (CCRC®) since 1999, and an active leader in ACRP global and Canadian initiatives for many years. She served as president of the Canadian Chapter in 2007–08, and later assumed responsibility for membership for the chapter. She also sits on the overall ACRP Membership Committee and its Chapter Affairs Subcommittee, and is an Item Writer for the CRC exam. Currently the director of clinical operations at Helix BioPharma Corp. in Whitby, Ontario, Canada, she has successfully launched two new business units, and has the experience to translate strategy into operations. She welcomes the opportunity to serve the ACRP membership in this manner.

John D, Irvin, MD, PhD recently retired from Vice President of Global Research & Development for Johnson & Johnson-Merck. He is a past President of the Academy of Pharmaceutical Physicians and Investigators (formerly AAPP) and served two years as Chair of the Nominating Committee of the Association of Clinical Research Professionals. His professional career, which spans more than 25 years in the pharmaceutical industry, has involved global management responsibility for a number of marketed products as well as compounds under clinical development. He has published more than 40 articles in refereed scientific journals as well as numerous abstracts and textbook chapters.

Dave Mastro, MBA, is vice president of pharmaceutical programs for the Strata Companies in Plymouth Meeting, Pa. He is also the cofounder and a past chair (now co-chair) of ACRP’s Data Management and Technology Forum, a member of the ACRP Editorial Advisory Board, a frequent contributor to The Monitor, and a frequent moderator and speaker at ACRP Global Conferences. He shared guest editing duties for the September 2005 “Technology and Data Management” issue of The Monitor and has also written for the Drug Information Association’s Forum.

Gary Shangold, MD, is founder, president, and managing member of the consulting firm Convivotech, LLC, in Califon, N.J. He has also served in various capacities with NovaDel Pharma Inc., Serono Laboratories, Johnson & Johnson, Massachusetts General Hospital, the Harvard University School of Medicine, and the University of Chicago Pritzker School of Medicine. He is board-certified in obstetrics and gynecology and subspecialty-boarded in reproductive endocrinology, and is a past president of the Academy of Pharmaceutical Physicians and Investigators.

Yafit Stark, PhD, joined Teva in 1987. From 1991 to 1994 she was based in the US, where she established the Innovative R&D Division of Teva USA and was responsible for the clinical development of Copaxone®. Dr. Stark then established and managed the Innovative R&D Division’s global clinical research and clinical development of all innovative products at Teva. Today she holds the position of Chief Clinical Officer, Innovative R&D Division and is in charge of the clinical development strategy and implementation of new methodologies in both innovative and biogeneric product development. She is an active member of “Tnufa”, the Project Funding Evaluation Committee of the Chief Scientist’s Office at the Israeli Ministry of Industry, Trade and Labor. She serves on the Board of Directors of the Israeli Research Association for Eye Health and Blindness Prevention and the International Association for Fighting Best Disease, and on the Advisory Board of Xenia Venture Capital, an investment company operating a technological incubator in support of high-technology startup companies in Israel.

Betsy Stein, CCRC, is the director of clinical research for Baylor Research Institute in Dallas, Texas. She has worked for Baylor Health Care System, primarily at Baylor University Medical Center, for more than 24 years, first in the areas of blood and marrow transplantation, oncology, and organ transplantation, and now planning and implementing educational classes and overseeing operations of the Clinical Trials Office spanning 10 hospitals and more than 700 projects. She received ACRP’s 2005 Innovation in Clinical Research award and is an active member of the ACRP North Texas Chapter.

Susan H. Warne, CCRC, is a senior project manager with D. Anderson & Company, a patient recruitment and retention services provider based in Dallas, Texas. Initially working as nurse for several years, she later began to focus on clinical research and now has more than 15 years experience in the clinical research industry. She became an ACRP Certified Clinical Research Coordinator® in 1994, serves as chair of the ACRP North American CRC Certification Exam Committee, and is also chair of the Publications Committee for the ACRP Greater Houston Area Chapter.

Liz Wool, RN, BSN, CCRA, CMT, president and CEO of QD-Quality and Training Solutions, Inc. in San Bruno, Calif., has worked for 19 years in the product development industry, including positions in biotech and pharmaceutical companies, investigational sites, contract research organizations, and academia. She become a Certified Clinical Research Associate (CCRA®) in 2000, and has served the ACRP Northern California Chapter as a member of its Education Committee, as vice president, and as president since 2008. On a global level, she holds appointments to ACRP Membership Committee and its Chapter Affairs Subcommittee, to the CRA Forum Steering Committee, and to the Editorial Advisory Board for The Monitor. She serves on the faculty for both the ACRP CRA and CRC Examination Review Courses, and has spoken at the ACRP Global Conference and at various events of the ACRP Chapters.

Non-Voting Member

James D. Thomasell, CPA, Executive Director, graduated from the Robert H. Smith School of Business at the University of Maryland in College Park, where he earned a Bachelors of Science Degree with a major in accounting. In 1997, he joined Deloitte & Touche as an audit manager in their federal government practice.  He was then assigned to a multi-disciplined team to re-engineer the audit process the Internal Revenue Service uses in its Small Business Self Employed division.  At the conclusion of this engagement, Mr. Thomasell was promoted to Senior Manager and worked in the Not-For-Profit division of Deloitte.  In 2000, Mr. Thomasell joined Volunteers of America, a non-profit organization headquartered in Alexandria, VA, as their Chief Accounting Officer.  He managed a team of 12 accountants and led the implementation of a new accounting software system.  He joined ACRP in 2005 as their Director of Finance & Administration.  He is a member of the American Institute of Certified Public Accountants.