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Clinical Services Staff

• Jacqueline J. Barrows, RN, CCRA, HP (ASCP), Clinical Trials Manager
• Kristine Bello now Associate Director of Clinical Project Management
• Molly Cook, Clinical Project Manager
• Christine Delano, RN-MSN, ANP, Senior Clinical Project Manager
• Lisa J. Dye, Clinical Project Manager
• Karin E. Graefe, Associate Director of Clinical Data Management
• Leslie Rose, Director, Clinical Services
• Nancy Roth, MPH, Clinical Project Manager
• Laiju Zhang, Ph.D, Senior Manager of Biostatistics and SAS Programming
• MDCI's Clinical Research Associate (CRAs)s

Jacqueline J. Barrows, RN, CCRA, HP (ASCP), Clinical Trials Manager
Jacqueline supervises, trains, and manages all in-house and contract clinical research associates (CRAs) to ensure that client studies are monitored and managed to meet both client expectations and relevant regulatory requirements. Jacqueline has over nineteen years of experience in clinical training and clinical research for medical devices, specializing in blood cell separation technology and urology. At Haemonetics Corporation, she oversaw clinical product training and managed clinical research to support aphaeresis and auto transfusion products. At UroMed Corporation she managed clinical studies in the development of a nerve stimulator device and various urological surgical instruments. She is an ACRP certified clinical research associate and graduated from the Clinical Research Administration Certificate Program at George Washington University in Washington, DC.

Kristine Bello, MPH, Associate Director of Clinical Project Management
Kris is responsible for overseeing the clinical services project management function while streamlining the department’s processes for maximum efficiency and customer satisfaction. She has specific experience with a range of cardiovascular medical devices. Prior to joining MDCI in 2007, she held senior clinical research positions at NMT Medical, Inc. and C.R. Bard, Inc. She also served as clinical education project manager at Beth Israel Medical Center in Boston, MA. Kris holds an M.P.H. from Boston University School of Public Health and a B.S. in veterinary science and technology from the University of Rhode Island.

Molly Cook, Clinical Project Manager
Molly works closely with clients to coordinate pilot, pivotal, and post-market clinical trial activities for a variety of in vitro diagnostic (IVD) products and systems as well as other medical device products. She has specific expertise supporting proteomic-based IVDs and infectious disease products.

Prior to joining MDCI, Molly held clinical research and clinical trial management positions at Matritech, Pleiad Devices, and Keystone Dental. She holds her B.S. in biology from the College of Mt. St. Vincent, NY.

Christine Delano, RN-MSN, ANP, Senior Clinical Project Manager
Chris works collaboratively to plan, organize and coordinate pilot, pivotal, and postmarket clinical trial activities for a variety of medical device and in vitro diagnostic products. She manages and oversee day-to-day activities to ensure that sponsors and study teams are informed and on track to meet study objectives. Chris has extensive experience with cardiovascular studies, specifically focused on stroke and congestive heart failure. Prior to joining MDCI in 2007, she was a clinical project manager for NMT Medical, Inc. and Cardiovascular Clinical Studies, Inc. She also held research positions at Tufts New England Medical Center and Fallon Healthcare System. Chris holds an M.S. in nursing from Massachusetts General Hospital and a M.S. in criminal justice from Northeastern University. She is a Nurse Practitioner and a member of the Association of Clinical Research Professionals.

Lisa J. Dye, Clinical Project Manager
Lisa works closely with clients to coordinate pilot, pivotal, and post-market clinical trial activities for a variety of medical device and in vitro diagnostic products. She works collaboratively with clients to maintain site and sponsor communication, assist with data management activities, and manage various periodic reporting requirements.

Prior to joining MDCI in 2001, Lisa held product development positions at Bayer Diagnostics (now part of Siemens Healthcare Diagnostics), where she was involved in the research and development of a variety of thyroid and folic acid reagents, systems and instruments. Lisa holds a Bachelor of Science in Biology from Washington State University in Pullman, WA and is a member of the Association of Clinical Research Professionals.

Karin E. Graefe, Associate Director of Clinical Data Management
Karin is responsible for leading the clinical trial data management group, and ensuring the delivery of state-of-the-art data services to meet clients’ changing needs. Karin works closely with project managers and study sponsors to design, build and implement clinical data solutions that will most effectively support client study requirements.

Karin joined MDCI in 2008 and brings over 13 years of experience in medical device and pharmaceutical clinical trials. She began her career at Massachusetts General Hospital as a clinical research coordinator and has held progressively senior clinical data management positions since 1997, for companies such as AstraZeneca, Wyeth Research, Accenture, Phase Forward, and BattelleCRO. Karin's experience covers a broad range of therapeutic areas, including oncology, neurology, cardiology, infectious diseases, respiratory diseases and rare genetic disorders. She graduated magna cum laude and holds a B.A. in social psychology from Wheaton College, where she was a member of the Phi Beta Kappa national honors society and Psi Chi, the national honor society for psychology.

Leslie E. Rose, Director, Clinical Services
Leslie oversees all activities of MDCI's Clinical Services group, consisting of project managers, data managers, SAS programmers, clinical trial managers, and biostatisticians. She has over sixteen years experience in the development and clinical research of medical devices. Before joining MDCI, Leslie was director of clinical research at Haemonetics Corporation, a global designer, manufacturer and marketer of blood management products and automated blood processing systems for donors and surgical patients. During her ten years at Haemonetics, Leslie created and managed a new clinical affairs department for the corporation, initially to conduct standard feasibility and pivotal trials. Her group then expanded in scope to manage post-market evaluations, investigator-initiated trials and competitive marketing studies. She also held positions at Dade Behring (now part of Siemens Healthcare Diagnostics) and at Boston University School of Medicine.

Leslie holds her M.S. in clinical laboratory science from the University of Rhode Island and B.A. in biochemistry from Mount Holyoke College.

Nancy Roth, MPH, Clinical Project Manager
Nancy works collaboratively to plan, organize and coordinate pilot, pivotal, and post-market clinical trial activities for a variety of medical device and in vitro diagnostic products. She serves as the primary contact for sponsors and oversees day-to-day activities to ensure that sponsors and study teams are informed and on track to meet study objectives.

Nancy joined MDCI in 2003 as a clinical data manager, responsible for database design, data collection, and data reporting for a variety of medical device studies. Prior to joining MDCI, she held data analysis and clinical research positions with the Massachusetts Department of Public Health, the Slone Epidemiology Center at Boston University, and the Cardiovascular Data Analysis Center. Nancy holds an M.P.H. from Boston University School of Public Health and a B.S. in biology from Northeastern University.

Laiju Zhang, Ph.D., Senior Manager, Biostatistics and SAS Programming
Laiju works closely with clients, project managers and data managers, often on complex projects, to write and implement appropriate data analysis plans, and provide FDA compliant reports, charts and tables. He provides critical interpretation of clinical study data based on established statistical methods and helps to identify methodological issues in need of customized solutions. Laiju is actively involved in the design and review of clinical protocols and case report forms (CRFs) as well as in database design, data collection guidelines, and edit logic checks.

Laiju joined MDCI in 2008 and brings over six years of CRO experience and three years of pharmaceutical experience with a strong background in theoretical and applied statistics and SAS programming. He is the author of several SAS macros designed for creating tables, listings, and statistical analyses for clinical trials, and his experience includes various therapeutic areas including CNS, cardiology, and oncology. Laiju holds a Ph.D. in philosophy from People's University of China, and a Ph.D.(ABD) of science and technology studies and a M.S. in statistics from Virginia Polytechnic Institute and State University.

MDCI's Clinical Research Associate (CRAs)s
Our CRAs have a broad range of clinical experience, as well as years of monitoring experience. On average, MDCI CRAs have over eight years of monitoring experience and over seventeen years of clinical expertise. All have an R.N. or health-related degree, or experience as a clinical study coordinator at a teaching hospital. In addition to its U.S.-based CRAs, MDCI maintains an affiliate network of experienced monitors in Western Europe, including the United Kingdom, and in South America and Canada.