Whether it’s mentoring, teaching, writing, or otherwise supporting others in the clinical trial industry, ACRP Fellows stand out as action-oriented visionaries dedicated to alleviating human suffering and prolonging life.
“It’s a higher calling and they’ve consistently answered to it for their entire careers,” says ACRP Executive Director Jim Kremidas of ACRP’s 2020 Class of Fellows. “That’s one of the many reasons we are so pleased to recognize their invaluable contributions to the greater good by naming them as part of ACRP’s 2020 Fellows class,” Kremidas adds.
Under more ordinary circumstances, ACRP Fellows would have been feted at ACRP’s annual conference in Seattle earlier this year, but the COVID-19 pandemic forced the cancellation of the event and forever changed the clinical trial landscape.
“Speaking on behalf of ACRP and its members, we’re honored to present the 2020 class with much admiration, respect, and deep thanks,” Kremidas says.
Here are brief biographies of each new member to ACRP’s exclusive club.
Suzanne Kincaid, CCRA, ACRP-PM, FACRP, has 25 years of clinical research experience, with 20 years in oncology. She has conducted clinical trials from every aspect, from being a study coordinator to a global project manager. She was the Study Delivery Program Leader for AstraZeneca’s Oncology Phase I Team and Director of Operations at Sarah Cannon. She is currently the Chief Operating Officer for Aperio Clinical Outcomes, which she joined after heading her own consulting firm for five years. With 15 years of project management experience, she is adept at cultivating high performing teams. Kincaid is also the Past President and current Treasurer of the Greater Nashville Chapter of ACRP.
Sandra “SAM” Sather, MS, BSN, CCRC, CCRA, FACRP, has more than 30 years of clinical experience, a Bachelor of Science degree in Nursing, and a Master of Science degree in Education with a specialization in Training and Performance Improvement. She has performed client clinical quality system gap analyses and facilitated improvement for efficiencies, cost containment, and audit readiness for the last 15 years. She is a subject matter expert in many Good Clinical Practice (GCP) areas, including monitoring, auditing, quality risk management, vendor oversight, and HIPAA and GCP regulations and guidelines. In 2002, she cofounded Clinical Pathways (CP), LLC, a consulting firm based in North Carolina. As Vice President of CP, she has led quality management consulting services with a focus on supporting the synthesis of changing regulations into the clinical quality systems of client organizations while supporting/developing an internal culture of change. Sather is dual certified as a CCRC and CCRA through ACRP and has served on the CCRA Exam Committee and the Academy Board of Trustees.
Lisa Ince, CCRC, CCRA, FACRP, is Clinical Operations Lead, Oncology, Clinical Solutions, at Syneos Health. She’s been in clinical research for 15 years, holding positions as a Clinical Research Coordinator (CRC), Internal Monitor, Study Manager, Clinical Research Associate (CRA), and Clinical Operations Lead. She obtained her certification as a CCRC in 2011 and as a CCRA in 2016 through ACRP. She has been on the ACRP Phoenix Chapter board since 2011 and currently holds the position of President. She was the winner of the New CRA of the Year award in 2016 and has been a judge during subsequent years. Ince is also currently the President of the CCRA Exam Committee, a guest instructor for a clinical research training group, and has presented at ACRP Phoenix Chapter meetings.
Cheryl Driver Levine, PhD, FNP, CPI, FAASLD, FACRP, is a nurse practitioner with a doctorate in Epidemiology from The University of Texas School of Public Health in Houston. Her Nursing degrees are from Vanderbilt University in Nashville, Emory University in Atlanta, and The University of Texas Medical Branch in Galveston. After teaching at The University of Texas at Houston School of Nursing for more than 30 years, she moved to become the Clinical Research Director for TCRI with responsibilities for designing and implementing clinical studies. Since 2000, she has served as a sub-investigator in more than 150 Phase I–III clinical trials in the areas of gastroparesis, IBD, HCV, NASH, and other liver diseases. She held the Certified Clinical Trial Investigator (CCTI) designation through ACRP since 2006 prior to receiving the Certified Principal Investigator (CPI) recognition in 2016. Levine has served on the Global CPI Exam Committee for six years and has assisted several students with their individual clinical research projects and presentations.
Lisette Gonzalez, CCRA, FACRP, is a clinical research professional with 25 years of experience in small start-up and large domestic and international corporations. Her background integrates scientific training with clinical trials, business management, monitoring, quality assurance, and client support responsibilities. As President of Phase 2 Phase Consulting, Inc., she enables organizations to achieve regulatory goals and requirements while maintaining compliance in all phases of clinical trials. In 2001, she achieved her Certified Clinical Research Associate (CCRA) status through ACRP. In addition, Gonzalez is a founding member of the ACRP New York Metropolitan Chapter, for which she has held various board positions since 2003, including serving as President in 2006 and for the 2013–14 term.
Liz Wool, RN, BSN, CCRA, CID, CMT, FACRP, has more than 30 years of clinical research experience and is a recognized industry subject matter expert, trainer, international speaker, published author, and Guest Editor for ACRP. Her expertise is in the areas of clinical research, trial management, monitoring, clinical quality management systems, vendor management and oversight, compliance, operations, personnel training and development, and performance management methods. Her passionate and focused attention to performance, performance management, and systems-strategic thinking in clinical research produces results in both organizational effectiveness and efficiencies (design, re-design, modifications for growing companies, and post-mergers and acquisitions) in support of the organization’s goals. Wool has a wide array of volunteer experience with ACRP, including serving with the Association Board of Trustees (two terms); as President, Vice President, and Education Chair for the ACRP Northern California Chapter; as presenter at ACRP annual conferences for 10 consecutive years; as a CCRA Exam item writer; as an Editorial Advisory Board member; and on the Membership Committee.
Joyce Ann Moran, CCRC, FACRP, is currently the NeuroNEXT Project Manager for the Columbia University Irving Medical Center-Weill Cornell Medicine sites in New York. She has 20 years of experience in conducting clinical trials in various areas such as neurology, oncology, infectious disease, and interventional cardiology, and has extensive experience in drug and device clinical trials (first in human trials to Phase IV/post-market trials) that are industry- or government-funded and conducted across multicenter U.S. and international sites. Additionally, she has coauthored several publications and has been extremely involved in the education of future/early clinical trialists and coordinators both at Columbia and within NeuroNEXT. Moran earned her CCRC through ACRP in 2013 and has been on the Board of Directors of the New York Metropolitan Chapter of ACRP since 2014, currently holding the position of Treasurer.
MeeLee Tom, MS, CCRA, ACRP-CP, ACRP-MDP, FACRP, has spent a career of more than 30 years in clinical research in major academic medical centers and is currently a Senior Research Project Manager at NYU Langone Health. She is dedicated to the advancement of science and medicine through the clinical research process by working in various disciplines, including psychiatry, neurology, anesthesiology, cardiovascular, pulmonology, and ophthalmology. She has worked on various multicenter, international clinical trials on the sponsor level, successfully bringing trials through their life cycle, and has been a coauthor on numerous peer-reviewed articles. A member of ACRP since 2005, she has been a CCRA since 2006 and an ACRP-CP since 2018, and has had her subspecialty certification as an ACRP-MDP since 2019. She served two terms on the CCRA Exam Committee and is currently in her first term on the ACRP-CP Exam Committee. Tom is also an active member of the New York Metropolitan Chapter of ACRP, having been a board member since 2018 and currently serving as Chair of the Education Committee.
David Vulcano, LCSW, MBA, CIP, RAP, ACRP-CP, FACRP, Vice President and Responsible Executive for Clinical Research at HCA Healthcare, is a well-known thought leader and change agent in the clinical research industry through numerous associations, boards, initiatives, publications, presentations, and contributions. He holds Master’s degrees in Social Work and Business Administration and the additional status of Certified IRB Professional (CIP) and Regulatory Affairs Certification (RAC). At HCA, he provides research-related compliance and strategy consultation to the organization’s portfolio of hospitals, physician practices, and healthcare technology companies. He is also the President of the Nashville Angel Capital Group. Vulcano’s contributions to the research industry are numerous, with the most recent recognitions including an Outstanding Speaker Award from the 2015 MAGI West conference, a Special Recognition Award by the Regulatory Affairs Professional Society, twice winning notice for Best Practice in Human Subject Protection from the Health Improvement Institute, and being named one of the Top 100 leaders in the Health IT Community by the HealthTech Council (through his leadership to assure the ethical conduct of clinical research with “big data” in healthcare).
Fellows are chosen annually based on several criteria, including:
- Holding ACRP membership in good standing for the previous consecutive five years prior to submitting an application for Fellowship status.
- Demonstrating evidence of active participation with the Association of Clinical Research Professionals.
- Demonstrating evidence of significant contributions to the field of clinical research.
ACRP’s 2021 Fellows class will be announced early next year.