New! Orientation to Clinical Research Billing Course (#09155) is available through the LMS
- Identify steps of the research billing process;
- Determine what the study team must do to ensure compliance;
- Your responsibilities for ensuring research billing compliance.
We offer the following types of services:
1) Individual Services, such as :
- IRB, FDA preparation and submission
- Coverage Analysis and budgets
- Coordinator support
- Data entry
These services are recharged on hourly basis:
2) Package Deals:
- Study Start Up
- Full Study Management
For Study-Start Up, our team will complete all start up activities, such as budget preparation and negotiation (with Department approval), IRB, contract, development of study logistics, and other approvals as needed. We transfer the study to the Department at the Site Initiation Visit. A typical study start up may take up to 6 months, and and valued over $20,000. The Department is not being charged during the start-up time; we recover our fees after the completion of the project and when the check is received from the study sponsor.
During Full Study Management the team is managing your entire clinical trial from the beginning to the end. We recover our costs from the industry payments.
For the Package Deals, CTSC team will be compensated from the funds negotiated in the industry budget. Departments are not charged separately for hours of work.
3) Coordinator on Retainer
- CTSC hires, trains, and supervises the Coordinators placed at the Department
- CTSC guarantees quality and compliance
- CTSC provides coordinator backup
- Department commits to a CRC percent effort in straight salary+ belenfits
- Minimum of 25%, maximum 80% effort, for at least 1 year
- In addition, Department may also choose 5-10% of the CRC Supervisor to assist the existing staff
Note to Junior Investigators and Scholars
New Investigators, those who have not yet competed successfully for a substantial NIH research grant but may have received a small grant (R03) or an Exploratory, Developmental Research Grant Award (R21) and Junior Investigators (within 10 years of completing a terminal research degree, medical residency, or equivalent) may request additional financial support. CTSC management will consider requests based on the scientific merit of the project.