ACRP Board of Trustees

Association Board of Trustees Core Values

Dedication
We value unwavering dedication to the clinical research profession, our stakeholders and our mission.
We strive for caring and passionate leadership in the delivery of effective and ethical programs.

Courage
We value having the courage to further the vision of the organization.
We value the courage to imagine what can be possible, speak what we believe is the truth, to be different, make difficult decisions, pioneer innovative solutions and adapt quickly to changing dynamics.

Communication
We value communicating openly, honestly and knowledgeably.
We promote active dialogue with all our stakeholders, fostering a learning environment and recognizing excellence.

Service
We value serving the clinical research community with commitment and passion.
We serve by listening to our stakeholders, understanding their needs and leading with conviction and humility. We are committed to building trusted and lasting relationships.

2012 Association Board of Trustees

CHAIR
Clara H. Heering, MSc, MSc, a member of the board since 2008, is senior director of clinical operations with Quintiles in Belgium, and a former director of that country’s Business Innovation Unit with Pfizer Global Research and Development. She has overseen Phase I–IV trials in several European countries as a clinical research associate and managed clinical research teams of up to 48 members in size. A former Research Fellow at Harvard Medical School, she also has influenced policy making in clinical research and risk management through health economics and outcomes research, and has served as an active board member of the ACRP Belgium Chapter since 2003. Clara has previously served as a member of the ACRP Nominating Committee, Awards & Recognition Committee and Global Conference Planning Committee. She currently serves as a member on the Regulatory Affairs Committee.

VICE CHAIR
Gary Shangold, MD, is founder and president of the consulting firm Convivotech, LLC, and of the start-up specialty pharmaceutical company InteguRx Therapeutics LLC, both in Califon, N.J. He has previously served in various capacities with a number of other pharmaceutical companies: chief medical officer at Xanodyne Pharmaceuticals Inc.; president and CEO of NovaDel Pharma Inc.; vice president and head of drug development at Johnson & Johnson Pharmaceutical Research & Development LLC; senior director of gynecologic and reproductive clinical research at RW Johnson Pharmaceutical Research Institute; and medical director at Serono Laboratories Inc. Gary has also held several academic faculty positions: clinical associate at Massachusetts General Hospital; associate clinical professor of obstetrics, gynecology and reproductive biology at Harvard University School of Medicine; and associate professor of obstetrics and gynecology at 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 former American Academy of Pharmaceutical Physicians (later known as the Academy of Pharmaceutical Physicians and Investigators and now as the Academy of Physicians in Clinical Research [APCR]). Gary has served on the ACRP Finance Committee since 2009 and also serves on the ACRP Ethics Committee and the Global Conference Planning Committee.

IMMEDIATE PAST CHAIR
Valerie Willetts, RN, BSN, CCRA^®, 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 six 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. Val has served as Vice Chair of the Ethics Committee, a member of both the ACRP Nominating Committee and the Global Conference Planning Committee, and continues to serve as a member of the Regulatory Affairs Committee.

TREASURER
John D. Irvin, MD, PhD, recently retired as Vice President of Global Research & Development for Johnson & Johnson-Merck. He is a past president of the Academy of Physicians in Clinical Research (formerly APPI) and served two years as Chair of the Nominating Committee of ACRP. 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. John has served on the ACRP Finance Committee since 2009 and currently serves as Chair of the committee.

Norbert Clemens, MD, PhD, is a board certified physiologist and a member of ACRP's affiliate, the Academy of Physicians in Clinical Research (formerly APPI). His broad exposure to worldwide healthcare issues includes service in several academic positions: as medical director for lntersan 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 past president of the German Society of Pharmaceutical Medicine and treasurer of the International Federation of Associations of Pharmaceutical Physicians. Norbert continues to serve on several ACRP and APCR committees as Chair of the APCR Nominating Committee and a member of the Editorial Advisory Board, Finance Committee, and Regulatory Affairs Committee.

Teresa-Lynn (Terri) Hinkley, RN, BScN, MBA, CCRC^®, is the director of Clinical Operations for Helix BioPharma Corp., a position she has held since July 2008. She has over 16 years of clinical research experience in the CRO and pharmaceutical industry. Terri graduated from Centennial College’s Diploma Nursing program in 1986, after which she gained experience in medicine, ICU and emergency. She completed her BScN in 2000 and her MBA in 2005. Terri continues to practice nursing in the Emergency Department of Rouge Valley Health System: Centenary site in Toronto on a casual part-time basis. Terri has been a member of ACRP since 1996, and completed her Clinical Research Coordinator Certification (CCRC^®) in 1999. She has been a member of the ACRP Canadian Chapter’s Education Committee since its inception and is the Past-President of the Canadian Chapter of ACRP. Terri is a member of the ACRP Membership Committee, ACRP Nominating Committee, and Vice Chair of the ACRP Regulatory Affairs Committee. She is a member of the Advisory Committee for the Clinical Research Associate Program at Seneca College and is an instructor in the Clinical Research Certificate program at the Michener Institute.

Brent Ibata, PhD, JD, MPH, RAC, CCRC^®, is a clinical research professional with over a decade of experience; from preclinical through all Phases of human clinical trials, including both in-patient and out-patient studies. Brent completed all three graduate degrees (PhD, JD, MPH) while working full-time in clinical research. As a former Project Manager of a $5.3 million Department of Defense clinical research study, he was responsible for initial grant writing, protocol development, database construction, regulatory submission and staff identification/hiring/training. Currently, Dr. Ibata is Director of Sentara Cardiovascular Research Institute. He has expert knowledge of FDA/ICH/GCP, with credentials in health law, clinical research, and regulatory affairs. Brent is an experienced member of several national clinical research committees and academic medical center Institutional Review Boards. He is the author of a research compliance column in the Association of Clinical Research Professionals journal - The Monitor.

Jeff Kingsley, DO, MBA, MS, CPI^®, FAAFP is founder and CEO of SERRG, Inc., a research management organization, the Institute for the Advancement of Clinical Trials, LLC, a research consulting organization, and other clinical research offices. A full spectrum of multi-specialty research is conducted at multiple offices across Georgia and he is nearing completion of offices in South Carolina and Mississippi. His medical degree was received from the Philadelphia College of Osteopathic Medicine in 2001 and he recently completed his MBA from Emory University’s Goizueta Business School. Following medical school, Jeff completed residency training in Family Medicine with the Columbus Regional Healthcare System and was hired as faculty immediately upon graduation. He has been director of several departments and holds faculty positions with the Medical College of Georgia. Additionally, Jeff has been President of an international non-profit organization, has two board seats, and sits on numerous committees including several for ACRP and APCR. Jeff has served on the ACRP Global Conference Planning Committee and the APCR (formerly APPI) Nominating Committee, and continues to serve on the ACRP Awards & Recognition Committee.

Dennis LaCroix, JD, received his BA and JD from Boston College. He has taught as Adjunct Faculty at Boston University and Suffolk University Law Schools, as well as a faculty member of the National Institute of Trial Advocacy (NITA). He is a member of the Massachusetts Bar, and is admitted to practice in the U.S. Supreme Court, the U.S. District Court for Massachusetts, and the U.S. Court of Appeals for the First Circuit. Most recently, Dennis served as the Vice President of Legal at Genzyme Corporation in Cambridge, MA, where he was involved in and provided services to clients in: Clinical Research, Advertising, Promotion and Labeling, Information and Records Management, Market Research, Compliance, and Healthcare. He has many years of experience in the health care and life sciences industries as an attorney in private practice and as in-house corporate counsel. Dennis is a frequent lecturer and presenter on topics of interest to the clinical research industry, and has presented several times at ACRP meetings. He has been involved with ACRP activities for many years, and has served as a member and Chair for both the ACRP’s Editorial Advisory Board for its publication, The Monitor, and ACRP’s Nominating Committee. He currently serves on the Professional Development Committee.

Fernando Martinez, PhD, MBA, brings a solid background in research and development with a robust experience in clinical research. In his role as Executive Director, Global Operations at inventive Clinical Solutions in Madrid, Spain, he is responsible for worldwide operations, including the oversight of corporate strategic alliances, and identification and evaluation of equity investments/acquisitions. Fernando serves on the ACRP Finance Committee and is founder and President of the ACRP Spain Chapter.

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^®. Yafit 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. Yafit has served on the ACRP Global Conference Planning Committee and the Awards & Recognition Committee and continues to serve on the Regulatory Affairs Committee.

Lynn Van Dermark, RN, BSN, MBA, CCRA^®, RAC, is co-founder and CEO of MedTrials, Inc. In addition to her management responsibilities, she currently provides training and senior-level consulting in regulatory strategy, clinical trial management, medical writing, SOP development, safety surveillance and quality assurance. She began her career in clinical research at the University of Texas Southwestern Medical Center, where she started as a senior research nurse in trauma and critical care. Since that time, she has functioned in numerous roles within the pharmaceutical, biotech and medical device product development industry. She is a well-known and dynamic speaker to industry and an entrepreneur. Lynn is adjunct faculty at the Graduate School of Biomedical Sciences at the University of North Texas Health Science Center and formerly at the University of Texas Southwestern Medical Center. She is also currently on the Nursing Advisory Board for the University of Virginia School of Nursing. Lynn has been an active member of ACRP since 1993 and previously served on the Professional Development Committee, Editorial Advisory Board and Vice Chair of the Global Conference Planning Committee. She is a charter member and past President of the North Texas Chapter of ACRP. Additionally, she has been a curricula developer, reviewer and faculty for ACRP, presenting workshops, conference sessions, seminars, webinars and certification preparation courses.

Liz Wool, RN, BSN, CCRA^®, CMT, is president and CEO of QD-Quality and Training Solutions, Inc. in San Bruno, California. She has worked for 19 years in the product development industry, including positions in biotech and pharmaceutical companies, investigational sites, contract research organizations, and academia. Liz earned her CCRA^® in 2000, and has served the ACRP Northern California Chapter since 2008 as a member of its Education Committee, as vice president, and as president. On a global level, she holds appointments to the ACRP Regulatory Affairs Committee and the Editorial Advisory Board for The Monitor. She has served as a member of the Membership Committee, on the faculty for the former ACRP CCRA^® and CCRC^® Examination Review Courses, and has spoken at the ACRP Global Conference and at various events for 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, Jim was promoted to Senior Manager and worked in the Not-for-Profit division of Deloitte. In 2000, Jim joined Volunteers of America, a non-profit organization headquartered in Alexandria, VA, as the 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 the Director of Finance & Administration. He is a member of the American Institute of Certified Public Accountants.