The Clinical Trials Innovation Unit (CTIU) provides a wide array of clinical research nursing and coordinator support and resources.
Investigators are encouraged to contact the CTIU at the beginning of grant or protocol development or prior to budget negotiations for industry sponsored research studies. However, the coordinator team is available to help investigators at any point during the course of a research study. Services are available for both investigator-initiated and/or industry sponsored research studies. TRI charges a fee for these services. Investigators can request CTIU coordinator support through the TRI Services Portal.
Once a request is made through the TRI Services Portal, a member of the CTIU will contact the investigator to discuss research needs. The team will then conduct a feasibility assessment and may require a meeting with the investigator and other members of the study team. Once CTIU support is determined, costs for coordinator support will be discussed.
For industry sponsored research studies, the CTIU will be available to discuss and help negotiate support costs with the sponsor. For grant proposals, CTIU support will need to be built into the grant’s budget. Early CTIU involvement in the study startup process will help maximize the potential to start the study in a timely manner.
CTUI coordinators are up-to-date on HIPAA, Human Subjects Protection, Good Clinical Practices and DOT-IATA certifications through various accredited programs. For studies that utilize CTIU 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 CTIU is available to assist with this process.
Clinical Research Nursing and Study Coordinator Support
CTIU 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
- Assist department financial analysts with invoicing
- Study closure (e.g., organization and submission of study closure documents)
- Routine and complex vital signs
- Assistance with biopsies
- Timed collection and processing of specimens
- Intravenous and oral glucose tolerance testing
- Participant observation
- Managing Investigational Product
- Medication administration
Program Leadership
Please submit requests for coordinator services through the TRI Services Portal. Select Research Nurses/Coordinators when completing the request form.