Roles & Responsibilities
It is important for everyone involved to understand his/her role in managing the research project and the roles and responsibilities for all personnel working on the project.
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 theG&CA Effort Reporting website.
- Obtain and maintain applicableIRB, ACUP, IACUC, DARapprovals 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
- 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
- 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.
The Pivot database includes pre-populated researcher profiles unique to VCU and others. This allows you to search for researchers by name, specific area of study or affiliation. Profiles include key biographical information, research interests, selected publications and contact information. They are editorially controlled and regularly reviewed for accuracy; however, you have the ability to update portions of your profile or create one if none exists.
Meet the ORBIT Team
Our Researchers & Collaborators
Martin Mangino, PhD ORBIT Associate Chair for Basic Science Research
Kirsty Dixon, PhD Researcher
Mazhar Kanak, PhD Researcher
Nicholas Thomson, PhD Researcher
Adam Klausner, MD ORBIT Associate Chair for Clinical & Translational Research
Jennifer Bradely, PhD Researcher
Ru Li, PhD Researcher
Caitlin Archambault ORBIT Lab Manager
Jad Khoraki, Post Doctorial Fellow
Loren Leicbrecht, Post Doctorial Fellow
Mary Baldecchi, Lead Clinical Research Coordinator
Jinfeng Han, Senior Clinical Research Coordinator
Andreea Marcue, Clinical Research Coordinator
Shawn Fenner, Internal Medicine, Collaborator, Clinical Research Coordinator
