FAU’s Division of Research Clinical Research Unit (CRU) was created to support, train, inspire and facilitate a network of research investigators who strive to conduct studies to bring innovative treatments, technology, interventions and possibly the development of new devices to improve the lives and health of research participants.
The CRU is located on the Boca Raton campus. The unit provides the tools, training and guidance to properly conduct clinical research. FAU’s Division of Research has dedicated staff of research professionals who are skilled in several aspects of clinical research, including study startup, project coordination and regulatory oversight. The CRU provides outpatient clinical research services. Some of the staff qualifications and procedures we perform include:
Project Management and Research Coordination
The CRU staff includes an experienced clinical research physician, project leaders, study coordinators, to provide human subject’s research protection and regulatory assistance and help investigators achieve their research goals while upholding compliance with all regulations and standards. In the initial phases of investigator-initiated research studies, the unit along with the Biostatistics Core, provides support on study design, biostatistics, epidemiology and health services research consultation.
Research Nurse and Certified Medical Assistant
Our facility is staffed with fully credentialed, basic life support certified registered nurse and certified/registered medical assistant. The nursing team members are skilled in advanced assessment, phlebotomy, administration of various routes of medication, audiometry, electroencephalogram, pulmonary function testing, optical coherence tomography and ECG.
Clinical Research Unit Space
The CRU unit is located in the first floor of the Office Building One, ME-104. The facility provides:
- Four exam rooms
- Two private cognitive testing rooms/consultation rooms
- Three infusion bays
- One comfortable waiting room for participants and family members with complimentary computer workstations.
Laboratory Specimen Collection, Processing and Storage
The laboratory is operated by experienced technicians who can perform specimen collection in addition to point of care testing. The staff follows study specific protocols to process, aliquot and store samples. The laboratory has
- One -80-degree Celsius freezer
- One -20-degree Celsius freezer
- Biosafety cabinet
- Short- and long-term specimen storage
- Procedures for immediate shipment to external laboratories
We have research coordinators with the expertise to execute cognitive subject testing for research. We have the capacity to provide simple and scientifically valid computerized tests to assess cognition. We can provide tests that involve evaluations for cognitive abilities of subjects which includes the processes of thinking, memory, language, judgement and subject’s abilities to learn new things. We provide two private testing rooms for this testing/evaluation.
This lab is equipped with an electronic walkway, which analyzes phases of gait, and provides numerous measurements such as velocity, step width, step length and weight bearing distribution. The 770 Inbody uses bioelectrical impedance to assess body anthropomorphic standards. The Falltrack II assesses postural sway, proprioception and balance. The BTE Evaltech utilizes electronically measured pressure to provide accurate muscle strength measurements.
We provide a comprehensive management of all facets of study agents, including ordering, Interactive Web Response System (IWRS)/randomization, receipt and secure climate-controlled storage (ambient and refrigerator controlled), preparation, accountability and record retention, returns/destruction, staff education and training and quality management.
Here’s How the CRU Can Help:
- Advising on study design and feasibility
- Assistance with Institutional Review Board (IRB) submissions
- Comply with Federal, state and institutional regulatory compliance and guidelines
- Training on Magnetic Resonance Imaging
- Coordination of Research studies involving
- Administration of research tests and procedures according to study needs
- Collection of data and specimen collection
- Shipping biological samples