The Study Coordinator Pool provides investigators with reliable and trained research staff to assist in the start-up, implementation, and closeout of clinical research studies. These services allow investigators to quickly implement and administer research studies and alleviate the administrative burden associated with training and managing research staff, and it allows investigators to utilize only the amount of effort required for a particular project.
Services
Study Coordinators can provide services in the following areas and can be requested in the CTSI Service Request Form by selecting ‘Study Coordinator’:
IRB & Regulatory
- Create IRB applications in eIRB after the finalized protocol is received
- Customize Consent form templates by individualizing subject, parental, and minor assent forms
- Prepare subject recruitment materials
- Response to IRB concerns
- Prepare and submit regulatory documents (e.g. 1572, Financial Disclosure Forms, CVs, etc.)
- Prepare and submit amendments to the IRB including revisions to the ICF
- Assemble Regulatory Binder
- Prepare study documents (e.g. source documents, participant visit packets, dosing cards, etc.)
Clinical Coordination
- Subject prescreening and subject recruitment
- Obtaining informed consent (after appropriate training by PI)
- Data collection
- CRF completion
- Specimen draw/processing
- Reconcile participant visit and other study milestones with invoices from Industry- Sponsored studies
- Complete study visits and perform/assist with required procedures
- AE and SAE reporting
- Ongoing liaison for all subject-related communications with PI/study team
- Ongoing liaison with external sponsor and PI/study team
- Schedule and implement monitoring visits
- Receive and inventory study supplies; unless it is an investigational product which requires storage in the Investigational Pharmacy
Fee-for-Service
- This service is free to early-career investigators and institutionally-funded pilot studies that are performed during the Study Coordinator Pool’s normal business hours. Please refer to the CTSI Hourly Services Pricing webpage for more information. Time allowed per investigator or per study will be monitored and adjusted based on need and overall demand for service
- All other investigators/studies will have access to this service for a fee. Investigators will receive monthly invoices for services and pay only for hours used. Please refer to the CTSI Hourly Services Pricing webpage for more information.
- These charges represent the cost associated with providing the service. Costs are monitored quarterly and may be adjusted annually to reflect the true cost of providing the service.