Staff

MELANIE FEIN, MD, CPI, DABFM
Medical Director
Dr. Melanie Fein is an experienced Principal Investigator and Medical Director of Phase One Clinical Trial Units. Her goals are to maintain participant safety while ensuring study integrity and producing high quality studies in a timely and efficient manner.Dr. Fein’s research experience includes participation as a Clinical Investigator in over 220 Phase One and Two Clinical Trials in multiple therapeutic areas.Dr. Fein is board certified in Family Medicine and has the Certified Physician Investigator Certification. She has worked with several major pharmaceutical companies and smaller Pharmas and CROs, receiving multiple commendations on the conduct of her trials. Between 2008 and 2010, Dr. Fein had two FDA audits on studies in which she was Principal Investigator. No 483 was issued for either study.

A “hands on” investigator her experience and expertise includes clinical trial conduct, set up of Phase One operational and clinical systems and staff training in the implementation of clinical trial systems.

 
MARGARITA NUNEZ, MD
Clinical Investigator
Dr. Margarita Nuñez received her medical degree from New York Medical College and did her residency in Internal medicine at the University of South Florida College of Medicine, where she taught for three years as an Assistant Professor of Internal Medicine and Geriatrics. She is a fellowship-trained geriatrician and is Board Certified in Geriatric medicine. After leaving the University of South Florida and before entering her work in clinical trials she practiced internal medicine for an additional three years.Dr. Nuñez is an experienced Principal Investigator with over 16 years of clinical trial experience. She has served as Principal Investigator in over 350 trials in both late and early phase. For 15 years she served as Medical Director and Principal Investigator for a late phase site in the State of Florida.

 
ANTONIO GUZMAN
Clinical Trial Manager
Antonio Guzmán graduated with a medical degree from ” Universidad Nuestra Señora de La Paz” school of medicine. Antonio has a strong background and understanding of medical aspects of clinical trials as well as experience as a coordinator in overseeing a number of Phase One clinical trials. His areas of expertise include overall study management including study conduct, subject safety, data collection and data entry supervision, staff training, quality assurance, screening and recruitment.

 
NITA JOHNSTON Pharm D, MS
Research Pharmacist
Dr. Nita Johnston Pharm D, MS holds a Doctorate of Pharmacy license from Campbell University and received her Masters of Science in Clinical Research Administration. Dr Johnston has been involved in clinical trials for the last twenty years in multiple therapeutic areas. She is dedicated full time to clinical trials at High Point Clinical Trials Center responsible for pharmacy management, all aspects of investigational product, and providing support to investigational staff and sponsors regarding study product, concomitant meds and blinding procedures.

 
ISSIS KELLY- PUMAROL
Screening and Recruitment Director
Issis Kelly- Pumarol Graduated from “Universidad Iberoamericana” School of medicine, Santo Domingo, Dominican Republic. Has dedicated most of her career to Clinical Research, from early drug development to post market research. With more than 6 years of experience, areas of expertise includes patient recruitment, screening, conduct of clinical trials and data collection.

 
MARSELA FERKO, FMG
Clinical Trial Manager
Marsela graduated with a medical degree in 2000 and has been involved in clinical trials for the past 11 years. She has a strong understanding of medical aspects and experience in overseeing Phase One clinical trials.

 
RICARDO A. SANCHEZ, RN, CCRC, FMG
Director of Clinical Services
Ricardo Sanchez obtained his Medical Degree In Columbia and was a Professor Of Surgery at Metropolitan University in Columbia. He obtained his Registered Nurse degree through New York State University in 1996 and is presently a Certified Clinical Research Coordinator.Mr. Sanchez is a committed research professional who has extensive research experience spanning nearly two decades, having actively participated in over 650 Phase One, Two, and Three clinical trials in numerous therapeutic areas. Mr. Sanchez has supervised a number of clinical trial departments leading to a broad based knowledge of the entire clinical trial process. He has been in a managerial position for over 12 years, training and supervising staff in the conduct of clinical trials.