Our medical director and principal investigator carefully oversees implementation and completion of each trial with the support of a clinical research staff of professionals including sub-investigators, site managers, recruiters, regulatory administrators, and clinical research coordinators.
As the medical director of Carolina Clinical Trials, David U. Lipsitz, MD, FACS, CPI has served as principal investigator for over 400 clinical trials. Dr. Lipsitz is a board certified urologist and a Certified Physician Investigator. He is a sought-after speaker on urological topics. In addition, Dr. Lipsitz currently serves as a Consulting Associate Professor at Duke University School of Medicine.
- Paola Natale, MD recently joined Carolina Clinical Trials as a Sub-Investigator to assist with endocrinology clinical trials. Dr. Natale’s interest are in diabetes, thyroid and hypogonadism. She is board certified in endocrinology and metabolism. Prior to moving to CCT she was an Endocrinologist with Novant Health Endocrinology and thyroid in Cornelius, NC. Dr. Natale served as an assistant professor at the University of Florida Department of Medicine, Division of Endocrinology and Metabolism with Dual appointment at Malcom Randall VAMC staff endocrinologist.
- Joseph M. Debord, MD, FACS has been a sub-investigator at Carolina Clinical Trials and a partner at Carolina Urology Partners for over ten years. Prior to moving to North Carolina, he was a Clinical Assistant Professor of Urology at West Virginia University.
- Richard Natale, II, MD is currently a physician with Carolina Urology Partners, and recently joined Carolina Clinical Trials as a sub-investigator. Dr. Natale currently serves on several boards at Carolinas Medical Center—Northeast.
Clinical Research Coordinators
Our clinical research coordinators (CRCs) are trained medical and research professionals responsible for the day-to-day activities of each clinical trial. Their qualifications include certification from the Association of Clinical Research Professionals, ICH/ Good Clinical Practice training, hazardous material shipping certification from the International Air Transport Association, and extensive experience with phlebotomy, uroflowmetry, electrocardiograms, bladder scans, and electronic data capture and interactive voice response systems.
- Karen Dziadziola, RN, CCRC has been a registered nurse for twenty-seven years, with over fifteen years in clinical research. Three of those years were spent as a cardiology clinical study coordinator with Carolinas Medical Center—Northeast. Ms. Dziadziola made her move to Carolina Clinical Trials in 2001 to assist Dr. Lipsitz in expanding his clinical trial site. Currently, she serves as the clinical research manager, regulatory specialist, and back up study coordinator and concentrates her effort on maintaining regulatory documents. In addition, her duties as a study coordinator include patient recruitment, study initiation, coordination and implementation of study-related patient visits, protocol-required testing, and study drug administration.
- Virginia (Jennie) Bridges, MLT (ASCP), CCRC has over twenty years of experience in medical laboratory technology. For the past several years, her primary focus has been in clinical research. Her role as Lead Clinical Research Coordinator at Carolina Clinical Trials involves the implementation of the clinical trial from initiation through the stages of development, recruitment of subjects covering informed consent and screening, communication with sponsors, visit coordination, time management and investigational product accountability, data collection and management, collection of source documents, CRF development, AE and SAE documentation, close-out of the clinical trial, audit preparation, communication with reporting authorities and final study report preparation. Jennie’s past experience includes working with a community bio-banking project in which she managed and instructed students and coworkers in laboratory safety, phlebotomy, and laboratory processing.
- Crystal Sharpe is responsible for accounts receivable and data input. After budget approval she is reponsible for all aspects of budget management She has over 20 years of payroll and accounts receivable experience.
We recently received this letter from one of our sponsors:
“[The] Trial Database Lock was achieved today, and we truly could not have met this milestone without your coordinators’ hard work and dedication to the trial! You were my highest enrolling site, which was an amazing achievement. In addition, yesterday when a database glitch appeared at the last minute, your coordinator went above the call of duty to ensure that we met our deadline. … Thank you.