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Clinical Translational Research Site (CTRS)

Office of Clinical Research
The Clinical Translational Research Site (CTRS) is an essential 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 provides a centralized clinical research infrastructure that benefits investigators across the University of Miami Miller School of Medicine and Jackson Memorial Hospital. As a Core & Shared Facility, the CTRS supports growth and investment in clinical and translational research at UMMSOM. Additionally, its cost recovery system is designed to provide a cost-effective solution for researchers to conduct their work while ensuring the sustainability and expansion of CTRS services.

CTRS offers two convenient, comfortable, and well-equipped locations for researchers to conduct their studies.

UHealth Tower (UHT)
West Building
1321 NW 14 Street
Suite 400
Miami, FL 33136

Don Soffer Clinical Research Center (DSCRC)
1120 NW 14 Street
7th Floor
Miami, FL 33136

CTRS has a highly skilled and experienced team of nurses, medical assistants, and clinical research coordinators prepared to service various protocols. To request our services, please complete the CTRS Request Form in our redcap survey link below:
CTRS Request Form

If you have any questions, please reach out to CTRSReservations@miami.edu

Please see the list of services provided by CTRS for clinical study support determined and classified by complexity below:

Nursing Services

Nursing Services - Complexity 1

Nursing service inclusive of vital signs and/or phlebotomy, or 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, or phlebotomy, or Room Use, or 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.

 

Laboratory Services

Laboratory Services - Complexity 1

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.

 

Others

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.).

CTRS Maintenance Fee

CTRS Maintenance Fee

 

A COVID-19 clinical trial that tests whether an anti-inflammatory drug may help hospitalized patients better recover from the disease has been underway, with Dr. Jay and the CTRS team performing the clinical trial. It was featured on Channel 10 News.

View WPLG Story