Introducing ACRP’s 2018 Class of Fellows

Being named a Fellow of the Association of Clinical Research Professionals (FACRP) is a mark of distinction. Launched in 2017, the ACRP Fellowship program recognizes those who have made substantial contributions to the Association and the industry at large, as evidenced by: ACRP certification/ACRP education, leadership contributions to ACRP, and contributions to the field of clinical research. Fellowship highlights excellence and commitment to ACRP, and is suitable for only a small, select number of clinical research professionals who are lauded as global leaders.

ACRP is proud to announce the 2018 Class of Fellows as the second in what aims to be a long and distinguished line. The new Fellows will be honored at the ACRP/AVOCA Awards and Recognition Ceremony on Friday, April 27, during the ACRP 2018 annual meeting.

Suheila Abdul-Karrim, CCRA, CCRT, MICR CSci, RQAP-GCP, FACRP, is an independent clinical research consultant providing services and training to pharmaceutical industry sponsors, clinical research organizations, clinical investigators, and clinical research associates (CRAs). Based in Johannesburg, South Africa, she has a post-graduate degree in science from the University of Witwatersrand with more than 21 years of clinical trials experience as a CRA, clinical research manager, auditor, and Good Clinical Practice (GCP) trainer. She has maintained her Certified Clinical Research Associate CCRA designation since 2000, and is actively involved with ACRP, previously as an item writer for the Global CRA Certification Exam and currently as Chair of the Professional Development Committee, for which she also serves as the Editorial Advisory Board Liaison. She is also the ACRP South African Chapter Chair and leader of the ACRP GCP & Ethics Interest Group.

Jeri Burr, MS, RN-BC, CCRC, FACRP, is Executive Director of the Trial Innovation Center at the University of Utah. A board-certified Pediatric RN, she is a clinical research management professional with two decades of experience in such areas as training, mentoring, and motivation of clinical research operations teams. She has a Master of Clinical Research Organization and Management degree. She also has broad regulatory experience, including coordinating industry-sponsored and National Institutes of Health–sponsored trials, and managing large investigator-initiated, multicenter clinical trials. Currently, she is a member of the ACRP annual meeting Content Advisory Board and serves on the Board of Directors for the Greater Salt Lake City Chapter of ACRP. As an advocate of improving children’s health globally, she served as a volunteer pediatric nurse on the USNS Mercy, a medical mission in the Philippines in 2012, providing pre- and post-operative nursing care to Filipino children. In 2015, she traveled to Africa, deep into the Zimbabwean bush on a medical humanitarian mission. As a Master Trainer for Helping Babies Breathe (HBB) and pediatric nurse volunteer, she taught HBB and provided clinical nursing care at various rural clinics throughout Zimbabwe.

Kelly Cairns, MA, BASc, APMR, CCRA, FACRP, is currently the Leader of Clinical Trial Operations and Business Support at Boehringer Ingelheim Canada Ltd, a large multinational pharmaceutical company in Burlington, Ontario, Canada. In this role she leads a team of more than 10 field-based positions, 25 in-house research staff, and three managers. Prior to this position she was the Manager of Investigational Supplies, Senior Research Associate, Research Associate, and Clinical Trial Administrator, all with Boehringer. Including the positions she has held at Boehringer, she has more than 25 years of research experience as a study coordinator, clinical research associate (CRA), and project manager in a vast array of therapeutic areas, including HIV/AIDS, metabolic, CNS, cardiovascular disease, dermatology, immunology, and respiratory. She completed her Master’s degree in Leadership Studies in addition to her Bachelor of Applied Science, both from the University of Guelph. She has served in many roles with ACRP, ranging from the Executive Committee of the CRA Forum, ACRP Canadian Chapter member, CRA Certification Exam Committee item writer/member, and Chair of the Global CRA Certification Exam Committee. She is currently serving as Chair of the ACRP Academy Board of Trustees. She has maintained her CCRA certification since 2001.

Stephanie Christopher, MA, FACRP, has dedicated her career to improving communication and developing tools to make clinical trials more efficient and patient-centered. She started her career with an academic public health team, working on interventions to improve the quality of communication between physicians and parents of newborns with abnormal newborn screening results. In 2012–13, she went on leave from her academic position to do a special assignment for the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, updating and training staff on a new risk communication process. In addition to her roles in advancing clinical research, she taught principles of effective communication as an adjunct instructor at Marquette University for five years. She has been a Certified Clinical Research Coordinator (CCRC) since 2008 and remains an active member of the Minnesota Chapter of ACRP.

Norbert Clemens, MD, PhD, CPI, FACRP, is a board-certified physiologist. 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 Vice President Clinical Operations at Impulse Dynamics, based in Stuttgart, Germany, his current position. He has been a board member of the research and development section of the German Association of the Pharmaceutical Industry, and has served as President of the German Society of Pharmaceutical Medicine and as Treasurer of the International Federation of Associations of Pharmaceutical Physicians for several years. He is a well-known trainer for investigators and site staff. He has served on the ACRP Board of Trustees as Vice Chair, Chair, and Immediate Past Chair, and is a charter member and Secretary of the German Chapter of ACRP.

Joy L. Frestedt, PhD, CCTI, RAC, FRAPS, FACRP, is President and CEO of Frestedt Incorporated and Alimentix, the Minnesota Diet Research Center. She has managed clinical trials, negotiated regulatory submissions, and updated quality systems for nearly 40 years in healthcare, pharmaceutical, medical device, and food industries, including for the University of Minnesota, Orphan Medical, Johnson and Johnson, AstraZeneca, CNS Therapeutics, Mayo Clinical Trial Services, Medtronic, and many others. She holds a PhD in Pathobiology from the University of Minnesota Medical School and BA in genetics from Knox College. She is among the “100 Most Inspiring People in the Life Sciences Industry” (PharmaVOICE, 2011) and top 25 “Industry Leaders” (Minneapolis/St. Paul Business Journal, 2011). She recently authored “Warning Letters: 2016 Reference Guide” with Barnett International and “FDA Warning Letters About Food Products: How to Avoid or Respond to Citations” with Elsevier. She has served on the ACRP Editorial Advisory Board and with the Global Exam and Regulatory Affairs Committees.

Michael R. Hamrell, PhD, RAC, FRAPS, RQAP-GCP, FACRP, CCRA, is the President of MORIAH Consultants, a regulatory affairs/clinical research consulting firm located near Los Angeles, Calif. He has worked in drug development, clinical research, compliance, and regulatory affairs for more than 30 years. He has also worked at the National Institutes of Health and as a reviewer in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration. He spent several years doing basic research, first as a Research Fellow at Duke University and later as an Assistant Professor of Pharmacology at the McGill University Cancer Center. He has a PhD in Pharmacology from the University of Southern California and a BS in Biochemistry from the University of California, Los Angeles. He is a Past Chair of the Editorial Advisory Board and has served on the Training and Development Committee with ACRP.

Joy Jurnack, RN, CCRC, CIP, FACRP, is with Northwell Health at North Shore University Hospital. A former Clinical Nurse Specialist for the Liver Transplant Team, she stumbled into research when introduced to it by a hepatologist. Initially certified as a CCRC in 1997, and recertified in 2003, she participated in clinical research in hepatology HCV/HBV, with the AIDS Clinical Trial Group, HIV/HCV in hemophiliacs, and synthetic hormones for post-menopausal women. She also assisted in opening a Phase I Dermatological Unit and taught Good Clinical Practice to investigators, and now works with chronic kidney disease patients with issues like anemia and high potassium. Through it all, she has maintained her clinical specialty in research on human subjects, and says that, as ACRP grows and contributes to the profession, she plans on being part of the growth and enriching the careers of young or not-so-young clinical research professionals. She serves on the Academy Board of Trustees and is a prior member of the ACRP Ethics Committee.

Anita S. Kablinger MD, CPI, FAAP, FAPA, FACRP, completed her undergraduate work at McMaster University and attended medical school at Rosalind Franklin University of Health Sciences before engaging in psychiatry residency training. She has conducted more than 160 trials as principal investigator or sub-investigator for industry, academic centers, and the National Institute of Mental Health over the past 20 years in academia. Areas of research and clinical responsibilities have included psychosis, mood disorders, and substance abuse. She has also been a Psychiatry Program Director for 15 years, mentoring undergraduate students, graduate level residents, and junior faculty in patient care, education, and research. Currently, she is a tenured Professor in the Department of Psychiatry and Behavioral Medicine at the Virginia Tech Carilion School of Medicine in Roanoke, Va. and the Director of the Clinical Trials Research Program. She serves as a member of the Global CPI Exam Committee and the Content Advisory Board for the ACRP annual meeting.

Kathryn L. Kimmel, CCRC, CCRA, ACRP-CP, FACRP, decided to explore opportunities in clinical research after working 15 years in a hospital-based laboratory. In the 22 years she has been in the clinical research field, she has worked as a clinical research coordinator (CRC), a director of a multitherapeutic clinic-based research department, a clinical research associate (CRA) and a regional manager of CRAs. She has also served as Chair for the Phlebotomy exam for NCA, and as a committee member and Chair of the ACRP Global CCRC Exam Committee. She is the current Chair of the Association Board of Trustees (ABoT) for ACRP, and has served as a board member and Chair of the Academy Board of Trustees and as ABoT’s liaison to the Academy Board. She has also served at Chair of the ACRP Governance Committee and as a member of the ACRP Nominating Committee. She was a charter member and served as President and Program Chair of the former Inland Northwest Chapter of ACRP. She has maintained her ACRP certifications for both CRC (20 years) and CRA (13 years), and is very passionate about certification and the value it brings to the industry. She is currently a Senior Clinical Research Associate with PRA Health Sciences.

David J. Morin, MD, FACP, CPI, FACRP, has been a principal investigator on hundreds of studies since 1989. He became a Certified Principal Investigator (CPI) in 2007 and Credentialed Clinical Research Trainer (CCRT) for ACRP in 2010. He received the “Outstanding Physician Leadership” award by ACRP/APCR in 2012. He co-developed the “CRC Bootcamp” and serves as a principal instructor for ACRP. He received his pharmacy degree with High Distinction at the University of Rhode Island, his MD with Honors at the University of Vermont, and residency training at the University of Virginia. He is a board-certified Internal Medicine specialist and is a Fellow of the American College of Physicians (FACP). He joined Holston Medical Group in 2008 as the Director of Research. He is a published author and speaker and has developed investigator-initiated trials. He is on the ACRP Board of Trustees and serves as a member of the Governance Committee.

Robert J. O’Connor, MS, CCRA, FACRP, is currently a Senior Clinical Scientist and Clinical Investigator in the BioSciences Department at The Procter & Gamble Company. He had earlier worked as a clinical research associate (CRA) at Kendle Research Associates in Cincinnati, Ohio, and at ClinTrials in Nashville, Tenn. He joined Procter & Gamble in 1994 and has worked on more than 260 clinical trials, of which he has been the principal investigator on 86. He has also been a full member of the company’s internal institutional review board. He has extensive experience in clinical research education and training and has been an adjunct professor in the Clinical Research Certificate Program at the University of Cincinnati since 2008. He has been a member of ACRP since 1992 and is a former item writer for the CCRA Exam, former Chair of the CCRA Exam Committee, and former Chair of the ACRP-CP Exam Committee. He was a founding member of the Greater Cincinnati Chapter of ACRP and currently serves as Chapter President. He has held his CCRA designation since 1996. He received the ACRP Exceptional Contribution to Clinical Research Award at the ACRP 2016 Global Conference.

Matthew D. Paul, MD, CPI, FACRP, is a recognized expert in cataract surgery and listed as a “Top Doctor” in Connecticut Magazine, Castle Connolly Top Doctors, and U.S. News & World Report. A participant in more than 16,000 cataract operations, he also is a Fellow of the American College of Surgeons and the American Academy of Ophthalmology. He has held his Certified Principal Investigator (CPI) designation since 2006 and has chaired the Global CPI Exam Committee for four years. He is a Phi Beta Kappa, Sigma Xi Graduate of Wesleyan University, where he earned High Honors for his Honors Thesis. He attended medical school at Columbia University College of Physicians and Surgeons and graduated with the Behrens Prize in Ophthalmology and the Spotnitz Prize in Oncology. As an intern in Internal Medicine at Beth Israel Hospital, he was recognized as “Best in the Emergency Room” and “PGY1 of the Year.” After his time as Chief Resident at the Harkness Eye Institute, he entered private practice in Danbury, Conn. He is President of an ophthalmology-subspecialty group of 14 doctors with additional offices in New Milford and Prospect, Conn. He entered the research arena in 1992 and has participated in more than 70 Phase I–III studies. He also has mentored more than 15 students who have contributed to more than 20 presentations at major ophthalmic meetings.

Deborah Rosenfelder, CCRC, FACRP, is currently a Clinical Data Scientist for Bard. She is responsible for review of data on a continuous basis and coding of adverse events, as well as coordinating the Clinical Events Committee and Data and Safety Monitoring Board meetings.  She has more than 36 years of healthcare industry experience. Therapeutic areas of expertise include critical and coronary care, oncology, cardiology, neurology, and device research. She began her healthcare career as a critical care nurse with 16 years of experience. For more than 15 years, she was a Research Coordinator at a large metropolitan teaching university overseeing drug and device trials. She has lectured on topics related to cardiology device and drug trials, recruitment, risk-based monitoring, and other research-related topics. She has been an active member of ACRP for more than 22 years, and is involved with the Medical Device Interest Group of ACRP as Chair. She also has served on the Editorial Advisory Board and the ACRP Global Conference Planning Committee, and is currently Chair of the Training and Development Committee. In addition, she is a Past President of her local ACRP Chapter.

Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, is Chief Implementation Officer at IACT Health, a multispecialty research management organization with clinical sites throughout the Southeast. She engaged in research in obsessive-compulsive disorder at Concordia University in Montreal, eating disorders at Douglas Hospital in Montreal, and pediatric oncology at the University of Vermont. Since joining IACT Health in 2007, she has worked as a Clinical Research Coordinator, Site Manager, and Chief Operations Officer before moving to her current role. She holds her PhD in Psychology and has Master’s degrees in both Clinical Psychology and in Advertising and Public Relations. She is certified by ACRP as a Certified Clinical Research Coordinator (CCRC), a Certified Principal Investigator (CPI), and a Certified Clinical Research Professional (ACRP-CP).

Clinical Researcher–March 2018 (Volume 32, Issue 3)

[DOI: 10.14524/CR-18-4016]