The Clinical Translational Research Site (CTRS) is an important inpatient and outpatient facility that operates under a fee-for-service model as part of the Office of the Executive Dean for Research (EDR) at the University of Miami Leonard M. Miller School of Medicine. It serves as a centralized clinical research infrastructure benefiting investigators across the University of Miami Miller School of Medicine and Jackson Memorial Hospital. The CTRS is a Core & Shared Facility that supports growth and investment in clinical research at UMMSOM. Its cost-recovery system is designed to provide an effective solution for researchers to conduct their work.
We provide guidance, training, facilities, tools, and services to support high-quality clinical research studies.
Non-nursing staff to perform routine data collection, sample handling, and processing, or shipping of specimens (dry ice included), etc.
1-5 blood tubes of processing or specimen processing.
Laboratory Services - Complexity 2
Non-nursing staff to perform routine data collection, sample handling, processing, or shipping of specimens (dry ice included), etc.
Pharmacokinetics Processing / 6-10 blood tubes of processing or specimen processing.
Laboratory Services - Complexity 3
Non-nursing staff to perform routine data collection, sample handling, processing, or shipping of specimens (dry ice included), etc.
Pharmacokinetics Processing / Mixed Meal Processing / PBMC Processing / 11-20 blood tubes of processing or specimen processing.
Laboratory Services - Complexity 4
Non-nursing staff to perform routine data collection, sample handling, and processing, or shipping of specimens (dry ice included), etc.
Visits that require more than 20 blood tubes to be processed or specimen processing.
Nursing Services
Nursing Services - Complexity 1
Nursing service inclusive of vital signs and/or phlebotomy, Room Use, or EKG, or Specimen Collection.
No medication administration. Survey studies. Low risk studies.
Nursing Services - Complexity 2
Nursing service inclusive of vital signs, phlebotomy, Room Use, or Specimen Collection, or EKG.
Moderate risk studies – IP Drug (PO route) with minimal risk of AE’s.
Nursing Services - Complexity 3
Nursing service inclusive of vital signs, phlebotomy, Room Use, Specimen Collection, or EKG, or Pharmacokinetics involvement for up to 12 hours.
IP Drug (IV, SubQ, or Nebulizing route) with Moderate risk of AE’s.
Mixed Meal Test – multiple vital signs and blood draw.
Nursing Services - Complexity 4
Nursing service inclusive of vital signs and phlebotomy, Nursing Observation and EKG, Room Use. Pharmacokinetics involvement greater than 12 hours.
After-hour coverage (Weekend and Night coverage). IP Drug (IV, SubQ, or Nebulizing route) with High risk of AE’s or moderate to full ADL Coverage.
Nursing Services - Complexity 5
Nursing service inclusive of vital signs and phlebotomy, Nursing Observation, EKG, Room Use. Pharmacokinetics involvement greater than 12 hours.
In-Patient protocols requiring patient care and complete nursing coverage or full ADL Coverage.
Other Services
Clinical Research Coordinator
Clinical research coordinator services are provided to work with a Principal Investigator to initiate, implement and manage clinical research studies.
Coordination of Site Qualification Visit SIV scheduling and participation.
Subject recruitment, prescreening, and scheduling.
Obtain Informed Consent (following the process mandated by Sponsor/PI).
Data collection/abstraction CRF completion/Data entry into local or external databases.
Complete study visits and perform/assist with required procedures AE and SAE reporting.
Act as liaison for all subject-related communications with PI/study team.
Sample Storage/ Specimen storage
Sample Storage/ Specimen storage monthly.
Medication Storage
Medication in a refrigerator/freezer or medication storage unit.
Protocol Review & Implementation
Protocol Review and Implementation covering time and effort to work with the study team interested in using CTRS resources (MD orders, flowsheets, etc.).
Professor Publications Biography:
Dr. Potter is a Professor of Clinical Obstetrics, Gynecology and Reproductive Sciences at the University of Miami, Miller School of Medicine, with joint appointments in the Department of Pediatrics and School of Nursing. She serves as Vice Chair of Research for the Division of Reproductive Sciences, and Chief of the Women’s HIV Service. As Chief of the Women’s HIV Service,... View Full Profile >
