Who We Are and What We Do
The Gillette Research Administration is responsible for managing Gillette’s portfolio of externally funded research studies and service agreements supported by governmental, nonprofit and private sector sponsors. We provide staff expertise and clinical research support for investigators conducting research that is aligned with established programs.
The department works closely with investigators, clinical, regulatory, and ancillary services staff in all phases of grant and contract management from pre-award proposal development and submission to post-award financial management to clinical research. Gillette Research Administration also maintains systems which support clinical research. General requests can be directed to research@gillettechildrens.org.
General Steps in the Process
Idea submission - Gillette providers, clinicians, and all staff are encouraged to submit ideas through supervisors and section chiefs to ensure alignment with departmental priorities and authorization to submit for scientific review.
Study intake is completed via REDCap to ensure study proposals are assigned to the appropriate Research Program for review by scientists and other experts (biostatistics, etc.).
Staffing analysis - study intake will also allow the Clinical Research Services unit to identify available staff, align staff expertise with study needs, and assign Clinical Research Coordinators (CRC). We will make every effort to assign CRCs early in supporting the study and to better understand evolving study requirements and more accurately structure funding requests.
SPA is Gillette’s signatory on all sponsored proposals and awards, offering assistance with proposal development, regulatory compliance, and meeting Gillette requirements. Investigators should contact SPA when planning to submit proposals external funding; this includes letters of intent, preproposals, and statements of interest.
Review funding announcement (notice of funding opportunity) – SPA and the PI will review funding opportunities to confirm PI and Gillette eligibility to submit the proposal.
Proposal development - SPA will schedule a series of proposal development meetings with the PI (CRCs may be included too) to identify required proposal elements, assign responsibility, and to ensure an accurate and complete proposal is ready for submission at least 2 days prior to the published deadline.
For further information, contact ResearchSPA@gillettechildrens.org.
SPA is also authorized to coordinate legal review, make budget adjustments which align with the scope of work, initiate regulatory approvals, and accept awards on behalf of Gillette.
PI/CRCs will work closely in submitting the IRB protocol, ensuring required training is completed, and creating regulatory binders and desk/working files.
Award acceptance - SPA will verify all final information, forward accounting attributes to Research Finance, issue sub-award and service agreements, and initiate the project kickoff meeting with scientific, CRC, and administrative staff.
Financial activation – Research Finance will establish a unique Project Account Number assigned to the study, set up the period of performance, expense budget by year, and in total.
Principal Investigators serve as project directors, ensuring scientific objectives are being met, technical reporting obligations fulfilled, and advancing knowledge within and outside of Gillette. Administrative staff assist investigators in managing awards by pre navigating policies, procedures, implementing financial restrictions, and maintaining regulatory compliance. Gillette’s systems and procedures are designed to make us audit-ready.
SPA will schedule the kickoff meeting with the study team.
PI describes the project, objectives, specific aims; CRC presents study calendar.
SPA summarizes legal obligations from the agreement.
Research Finance reviews PAN for period of performance, assigned staff, expense budget, and manages invoicing/expense reporting and payments.
Study closeout requires collaboration between the PI (science), SPA (administration), Research Finance (account closure), and CRC (regulatory closure). Studies are deemed ready for closeout when:
Specific aims and objectives have been met.
Funds are completely spent.
Period of performance has ended, or early termination occurs.
Manuscript review, re-analyze data, revise conclusions.
Publication and dissemination of results.
Audits.
News stories/media attention.
Human Subjects Protection
Gillette Research works collaboratively with researchers and administrative units from the University of Minnesota and many other organizations. Funding sponsors may require PIs, key personnel, and study staff to complete training in various research topics including:
- Human Subjects’ Protection: The Collaborative Institutional Training Initiative (CITI) online tutorial hosted by the University of Miami Medical School Server. This must be renewed per IRB requirements, which vary from IRB to IRB.
- HIPAA/Privacy: Training at Gillette or proof of training at your primary institution.
- Conflict of Interest: Completion of the FCOI online training module or proof of FCOI training from home institution. Training must be updated annually and renewed every four years.
- Responsible Conduct of Research and other training required by the sponsoring organization.
Research Policies
Find out more about Conflict of Interest in Research by sending an email to research@gillettechildrens.com.
Research Questions
Call Research Administration at 651-229-1745 or email research@gillettechildrens.com.