Roles and Responsibilities
Of paramount importance is the Principal Investigator’s (PI) freedom to choose the nature and direction of research program and to disseminate the results of that research to the public, within any constraints placed by the funding agency. To ensure compliance with many complex federal and VCU policies and responsible conduct in research, it is important for the PI to understand his/her role in managing the research project and the roles and responsibilities for all personnel working on the project.
- Understanding and complying with the award’s terms and conditions as specified in the Notice of Grant Award
- Ensure expenditures are in accordance with sponsor and university regulations, policies, and procedures (soon to be available via the Research Dashboard)
- Coordinate approvals for restricted expenditures with division/department fiscal administrator
- Maintain knowledge of and compliance with University policies and procedures related to sponsored research, including disclosure of financial conflicts, prior disbarment/suspension, etc.
- Certify effort reports for all staff working on the project. For first time PIs, effort reporting information and training is available on the G&CA Effort Reporting website
- Obtain and maintain applicable IACUC, IRB, IBC, and EHS approvals before initiating a research project
- Ensure that all other personnel employed by the project understand their roles and responsibilities related to the research project and have received required training to carry out those responsibilities
- Preparation and submission of all technical/progress reports required by the sponsor
Postdocs and graduate students are to:
- 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 related to the research
- Obtain applicable training in and practice responsible conduct of research
- Obtain applicable IACUC, IRB, IBC, and EHS approvals/training
Clinical Research/Study Coordinator and Responsibilities
- 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.
- For industry sponsored clinical trials, report CRF/billing milestones to the index fiscal administrator to ensure timely collection of funds from the study sponsor
DOIM Research Services Office Responsibilities
- 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
- Work with division personnel to ensure monthly review of project costs and obtain PI approval of same in a timely manner