Roles and responsibilities in research administration
Offices supporting research at UVA
The award process at UVA (offices, timelines)
Specific roles and responsibilities of:
Clinical research coordinators
Department research administrators
The award process at UVA. All grant and contract proposals must be approved by the University before submission to the sponsor. At the SOM, proposals must be endorsed by the Principal Investigator, Chair, and the Office of Grants and Contracts.
The fiscal/administrative description of the proposal and approval signatures are collected on a four-page proposal approval sheet (also known as "the goldenrod," after its former color). Grants and Contracts has posted a version for NIH e-SNAP proposals and a generic SOM version. Your research administrator should help you complete this form, though you, as Principal Investigator, are responsible for reviewing and approving its contents. The approval sheet, technical proposal, budget, justification, and other supporting documents are forwarded to your Chair and then to Grants and Contracts (who require at least five working days before the submission deadline). Grants and Contracts may ask additional questions concerning the project or information on the approval form before it is signed and ready for submission to the funding agency. Grants and Contracts performs all electronic submissions of proposals to grants.gov (see notes and reminders for submissions to grants.gov at their site). See detailed information on the proposal submission process and how to avoid pitfalls. You can follow the progress of your grant proposal at the Grants and Contracts tracking log (intranet).
If your NIH proposal is likely to be funded, you will be asked to submit just-in-time documentation of other grant support, IRB or IACUC approvals, etc. You can send these directly to NIH, or via Grants and Contracts.
Sponsors generally notify both the PI and either Grants and Contracts or Sponsored Programs. Sponsored Programs then creates an internal account in the Oracle system, which may take a few weeks to complete. To avoid delays in initiating your project, ask your department administrator to request a preliminary Oracle account as soon as it is likely that your project will be funded. This will allow you to encumber and spend funds in a timely manner.
Faculty research roles and responsibilities. Faculty have the freedom to choose the nature and direction of their research program and to disseminate the results of that research to the public, within any constraints placed by the funding agency. Non-PI faculty have similar responsibilities to the PI, with the exception of overall responsibility for project direction and reporting. Collaborating investigators must:
- Ensure that their expenditures are in accordance with sponsor and university regulations, policies, and procedures
- Coordinate with the PI any approvals for restricted expenditures (e.g., equipment)
- Maintain knowledge of and compliance with University procedures related to sponsored research
- Disclose financial conflicts of interest to the PI
- Obtain and maintain applicable IACUC, IRB, IBC, and EHS approvals before initiating a research project
- Disclose prior disbarment/suspension or proposed disbarment
- Verify that their project staff have signed University Patent Agreements
Faculty conducting human subjects research should also refer to the section below on the roles/responsibilities of clinical research coordinators.
- Seek and follow faculty guidance on scientific and other procedures (e.g., allowable uses of grant funds)
- Maintain knowledge of and compliance with University procedures and policies related to sponsored research
- Disclose financial conflicts of interest to the PI
- Obtain applicable training in and practice responsible conduct of research
- Obtain applicable IACUC, IRB, IBC, and EHS approvals/training
- Manage all aspects of conducting clinical trials under the direction of the PI
- Maintain in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) as set described in FDA regulations
- Provide sound conduct of the clinical trial (including recruitment, screening, enrollment, and follow-up of eligible subjects per protocol)
- Maintain accurate and complete documentation (e.g., regulatory documents, signed consent forms, IRB approvals, source documents, drug dispensing and subject logs, and study-related communication)
- Provide organizational management of all aspects of the trial (e.g., timeliness in completing case report forms, data entry, reporting adverse drug experiences [ADEs], and managing caseload and study files)
- Communicate protocol-related problems to the management staff (e.g., questions regarding the conduct of the clinical trial, possible ADEs, or subject compliance)
- Maintain professional conduct in the presence of subjects, research staff, sponsors, monitors, auditors, etc.
- Support project investigators in the development of proposals and related financial narratives and budgets
- Thoroughly understand unallowable, direct, and facilities and administrative (F&A) costs.
- Thoroughly understand and properly follow Cost Accounting Standards
- Show consistency in charging sponsored award costs
- Ensure monthly review of project costs and obtain PI approval of same in a timely manner