Staffing and Services
The Clinical Research Unit Offers Nursing, Lab Access and Other Services for Research Studies
The Clinical Research Unit provides staff and services to help facilitate all research projects. The following is an overview of the staffing and features available for researchers.
University Hospitals Clinical Research Unit Services offers highly specialized adult and pediatric support for inpatient and outpatient studies in the research-dedicated facilities and scattering throughout University Hospitals Cleveland Medical Center campus.
To help support our researchers and research studies, our staff:
- Develops protocol-specific order sets and flow sheets
- Conducts GCP-compliant protocol initiation conference to confirm all stakeholders in agreement on protocol
- Provides research-focused clinical care for adult and pediatric subjects
- Administers and monitors responses to investigational study agents and interventions; collects research data
- Performs venipuncture, body fluid specimen collection and processing, and performs physiological measurements
- Conducts pharmacokinetic studies
- Conducts glomerular filtration tests
- Assists with bedside procedures including biopsies, endoscopies, bronchoscopies.
- Specialty procedures/equipment include adult and pediatric SphygmoCor
State-of-the-art resources, gold-standard methodologies, and an experienced and skilled staff help support the nutritional needs of research studies. Resources can be provided for inpatient and outpatient studies within clinical research units or in other settings for community research.
Bio-nutrition services include:
- Consultation services clearly develop and help plan the nutrition component of the protocol, as well as provide assistance in grant submission and manuscript preparation
- Fully equipped, Clinical Research Unit staffed, and licensed metabolic kitchen for meal preparation, which can range from regular diets to nutrient-controlled metabolic diets
- Interventionist support for patient education, counseling and coaching
- Customized nutrient analyses of diets using gold-standard research software, Nutrition Data System for Research (NDSR)
- Call center service for collecting 24-Hour Dietary Recalls
- Training site for students interested in human nutrition research
- Master training for anthropometric assessment available for study teams
- Anthropometric measurements, bioelectrical impedance analysis (BIA), and skinfold thickness technique available to assess body composition status
- Additional body composition techniques available on a site-by-site basis include air displacement plethysmography (BodPod)
CLIA-Certified Sample Processing & Analytical Lab
The Sample Processing & Analytical Lab at University Hospitals Clinical Research Unit provides service customized to the needs of each individual protocol, and includes specimen tracking and inventory.
- Provides consultation regarding any specimen-related issues, including appropriate methods for analysis, collection, processing and storage
- Has the ability to develop new assays and adapt existing assays to investigator-specific needs
- Assists investigators with finding analytical support for assays not run in the DCRU or UHFLS lab
- Maintains sample management protocols and rigorous quality assurances procedures to consistently provide high-quality samples for downstream analysis
- Performs simple and complex sample processing (such as PBMC and DNA isolation) on biological samples.
- Runs assays for hormones, cytokines, etc. using ELISA, EIA and multiplex techniques
- Provides domestic or international DOT/IATA-certified shipment support
- Provides sample storage service
Storage and equipment features include:
- 4°C, -20°C, and -70°C storage
- Liquid nitrogen storage
- All freezers and refrigerators are remotely monitored 24/7 for immediate response to any power failures
- Refrigerated and room temperature centrifuges and microcentrifuges
- SpectraMax 190 Microplate reader, Meso Scale Discovery Multiplex analyzer, YSI Glucose analyzer, NanoDrop 2000c UV-Vis spectrophotometer, Qubit Fluorometer, and Class II Biosafety Cabinet
- Temperature logs, calibration logs and laboratory equipment maintenance logs available upon request
Research Coordinator Core
Research coordinator features include:
- Fee-for-service staffing to meet your project management needs
- Project start-up, hiring, HR oversight provided by the Clinical Research Unit
- Nurses or non-nurses, depending on protocol study coordination needs for research subject visits
- Staffing support may be requested by % effort over a period of time
Informatics staff provide:
- Training and consultation supporting REDCap database design, data management, data format conversion, and preliminary data analysis
- Explorys training
Research Subject Advocate
The research subject advocate serves as a resource on matters of human subject safety, data monitoring, and federal regulations on research.