The Study Coordinator Pool provides investigators with reliable, experienced 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. These services allow investigators to quickly implement and administer research studies and alleviate the administrative burden associated with training and managing research staff. This service allows investigators to utilize only the amount of effort required for a particular project.
IRB & Regulatory
- Create IRB applications in eIRB
- Consent form development
- 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.)
- Subject prescreening and subject recruitment
- Obtaining informed consent (after appropriate training by PI)
- Data collection
- CRF completion
- Specimen draw/processing
- Financial tracking
- 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 all study supplies
- This service is free to early-career investigators (learn more about the qualifications for early-career faculty) and investigator-initiated pilot studies fitting the institutional definition. 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. Coordinator services will be charged at a rate of $40/hour for investigator-initiated studies and $60/hour for industry studies. 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.
To request Study Coordinator Pool assistance, please complete the Service Request Form. Investigators interested in learning more about the Study Coordinator Pool can also email Shepeara Hall at firstname.lastname@example.org.