Clinical Research Coordination & Facilities

The Clinical Research Team (CRT) of the Clinical Trials Innovation Unit (CTIU) provides a wide array of coordinator support and resources, including nursing and research coordinator support, regulatory support, participant recruitment, specialized research space and lab processing, mobile support and more. Clinical research coordination and regulatory activities are fee-based services.

Investigators are encouraged to contact the CRT at the beginning of grant or protocol development or prior to budget negotiations for industry sponsored research studies. However, the CRT is available to help investigators at any point during the course of a research study. CRT coordinator and regulatory services are available for both investigator-initiated and/or industry sponsored research studies. TRI charges a fee for these services. Investigators can request CRT coordinator and regulatory support through the TRI Services Portal.

Once a request is made through the TRI Services Portal, a member of the CRT will contact the investigator to discuss research needs. The CRT will then conduct a feasibility assessment and may require a meeting with the investigator and other members of the study team. Once CRT support is determined, costs for coordinator and regulatory support will be discussed.

For industry sponsored research studies, the CRT will be available to discuss and help negotiate coordinator and regulatory  support costs with the sponsor. For grant proposals, CRT support will need to be built into the grant’s budget. Early CRT involvement in the study startup process will help maximize the potential to start the study in a timely manner.

CRT members are up-to-date on HIPAA, Human Subjects Protection, Good Clinical Practices and DOT-IATA certifications through various accredited programs. For studies that utilize CRT support, we require all members of the research team to be certified in HIPAA, Human Subjects Protection, Good Clinical Practices and other study specific certifications. The CRT is available to assist with this process.

Research Coordinator and Nursing Support
Regulatory Support
Participant Recruitment
Specialized Research Space & Lab Processing
Mobile Support

Research Coordinator and Nursing Support

CRT coordinators are available to assist investigators with the day-to-day conduct of research studies. Services include:

  • Conduct of study related visits and procedures (e.g., participant screening, participant education, scheduling, consenting, enrollment, questionnaires, and preparation and shipping of specimens)
  • Data collection and management (e.g., creation of source document templates, completion of case report forms)
  • Mentoring services (e.g., training investigative staff)
  • Assistance with protocol monitoring and auditing visits
  • Research billing reviews
  • Assist department budget managers with invoicing
  • Study closure (e.g., organization and submission of study closure documents)
  • Routine and complex vital signs
  • Assistance with biopsies
  • Timed collection of blood specimens
  • Intravenous and oral glucose tolerance testing
  • Participant observation
  • Managing Investigational Product
  • Medication administration

Regulatory Support
Regulatory managers are available to assist investigators with submissions and reports to sponsors and/or institutional oversight bodies. Services include:

  • Submission of protocols, modifications and amendments
  • Working with sponsors and study teams to complete required start-up regulatory packets
  • Reporting of adverse events, continuing reviews and study closure
  • Maintenance of regulatory binders
  • Preparation and guidance throughout monitoring visits and audits

Participant Recruitment
The CRT is available to assist investigators with developing a study recruitment plan for investigator initiated and industry sponsored studies. Services include:

  • Facilitating the use of ResearchMatch and ARresearch (online web portals that connects participants with researchers) and a mobile text alert service that notifies participants of opportunities to participate in research
  • Creating and distributing recruitment materials (e.g., print advertisements and direct mail items)
  • Managing relationships with media outlets (e.g., newspapers and radio)
  • Assist investigators with social media strategies (e.g., Facebook, Twitter)

Specialized Research Space & Lab Processing
The CTIU is located on the 3rd floor of the Reynold’s Institute on Aging and has designated research space including:

  • Participant waiting area and research restrooms
  • Secure, short-term storage rooms for study files and participant folders
  • Secure medication room
  • Eight outpatient procedure areas with access to
    • Exam tables
    • Detecto Scales
    • Wall mounted Stateometers
    • Phillips B/P Machine: B/P, P, T, O2, and MAP capability
    • ECH Machine
  • Space for investigators to conduct participant visits
  • Distance health telemedicine unit
    • A designated research teleconferencing video unit which enables two-way live video and audio interaction with 75 counties and 135 Arkansas communities, including hospitals, community health centers, libraries, mental health clinics and home agencies. The unit can be utilized for recruitment initiatives, connecting with subjects who are unable to travel to the UAMS central campus or to educate other areas of the state about research.
  • Specimen processing lab
    • -20°C and -80°C freezers (for storage of specimens up to 12 months)
    • Hettich refrigerated centrifuge
    • General laboratory equipment for sample collection processing and shipment

Mobile Support
TRI’s CRT offers mobile support, including travel to the following locations:

  • UAMS Medical Center and any other location on the UAMS central campus
  • Freeway Medical Tower
  • Arkansas Children’s Research Institute
  • Recovery Centers of Arkansas
  • Central Arkansas Veterans Healthcare System
  • And many more

Program Leadership

Cynthia Witkowski
Cynthia Witkowski, BSN, RN
Mtonya Hunter-Lewis
Associate Director, Regulatory Support