Theresa Harris, ARNP, works with research nurse Stephanie Hamilton (far right) to examine a patient as part of a rheumatology study.
The Center for Clinical and Translational Research (CCTR) houses a team of experienced clinical research staff called the Clinical Research Staff Support Core (CRSSC). Staff from this core are available to support and collaborate with investigators and their research teams in all phases of clinical research, providing services that include assisting with the organization, implementation and completion of clinical research trials.
Services
The Clinical Research Staff Support Core is made up of dedicated research staff with expertise in protocol management, study implementation and study coordination. The core consists of clinical research assistants, clinical research associates (I and II) and a research nurse. Core resources are dependent on staff availability.
The following services are offered to investigators upon request:
- Study Start-up
- Preparing and submitting:
- Institutional Review Board (IRB) application
- Scientific Review Committee (SRC) application
- Protocols
- Consent forms
- Approach letters/recruitment materials
- Completing regulatory forms and gathering regulatory documents: Significant Financial Interest (SFIs), curricula vitae (CVs), licenses, CAP (College of American Pathologists) and CLIA (Clinical Laboratory Improvement Act/Amendment) laboratory certifications and FDA 1572
- Coordinating and facilitating site-initiation visits
- Coordinating hospital service setup (e.g., Research Specimen Processing Laboratory, laboratory, radiology, Heart Center)
- Designing simple databases (Excel and Access)
- Study Coordination
- Recruiting and screening patients
- Assisting with determining eligibility
- Obtaining consent for minimal-risk studies
- Scheduling research procedures
- Facilitating research visits
- Coordinating shipment of research specimens
- Managing data collection
- Preparing and submitting IRB and SRC amendments and renewals
- Explaining study basics to patients and families
- Facilitating study monitor visits
- Coordinating Data and Safety Monitoring Board (DSMB) meetings
- Assisting clinical staff in monitoring and reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Study Closeout
- Coordinating and monitoring study closeout visits
- Verifying that studies meet IRB standards for study closure
- Preparing and submitting IRB and SRC closure notification
- Performing data resolution
- Facilitating research file and data storage
Location and Hours of Operation
The Clinical Research Staff Support Core is located in the Clinical Research Center (W-6605) on the main hospital campus.
Core staff are available Monday through Friday, during regular business hours. Extended and weekend hours are available upon request, with approval of Pam Joy, CCTR clinical operations director.