Clinical Research Financial Management
The financial management of clinical research studies is complex, and can be confusing for even the most experienced researchers. An experienced team of experts in the Clinical Research Support Unit and Research Finance Operations is here to help. Working with the Office of Science and Research, we handle many aspects of the financial management process, beginning in the preaward phase all the way through to postaward to ensure that the study’s financial management needs are met.
Clinical Research Support Unit
The Clinical Research Support Unit is responsible for reviewing all incoming studies via the Clinical Research Management System to ensure they are complete, as well as working with study teams to gather the required documents. Clinical Research Support Unit operations specialists serve as the primary liaisons between the study investigator and central offices on all preaward budget matters, and negotiates with the study sponsor(s) until a satisfactory reimbursement schedule is obtained.
NYU School of Medicine’s Clinical Research Support Unit finance team manages postaward activities for all non-federally sponsored clinical research projects, such as industry-sponsored awards, as well as non-federal investigator-initiated trials and foundation milestone-based trials. Clinical trial postaward analysts review and evaluate all non-federally sponsored clinical research accounts, ensure accurate and timely payments from industry clinical trial sponsors, and monitor the appropriateness of clinical trial expenses.
For questions regarding billing for active clinical trials, submit queries to email@example.com or call 646-754-7430.
Research Finance Operations
Research Finance Operations manages the financial postaward process for all sponsored projects at NYU School of Medicine. Responsibilities include, but are not limited to, preparing and submitting all financial milestones and deliverables; ensuring the regulatory and compliance monitoring of all grant and contract expense allocations; and overseeing financial reconciliation from budget to collections. Research Finance Operations also provides recurring training and guidance to the research community covering general postaward management from reporting to billing and compliance.
To assist those conducting clinical research, Research Finance Operations works with the Clinical Research Support Unit and Sponsored Programs Administration in the postaward phase to set up all clinical research projects in PeopleSoft, the financial system used by NYU Langone. In the postaward phase of the project, Research Finance Operations billing specialists generate invoices based on milestone completion and activities that can be invoiced and submit invoices to the sponsor for payment. All clinical research payments are then applied to the project account.
Upon completion of the study, Research Finance Operations and the Clinical Research Support Unit works closely with the department conducting the study to reconcile the project account and complete the financial closeout of the project. Study teams logging in with their Kerberos ID can access numerous additional resources regarding clinical research finance.
For questions regarding Research Finance Operations activities, contact us at firstname.lastname@example.org.
Clinical Research Financial Process Timeline
Specific financial processes differ based on the funding account type, which may be a nonfederal grant award, a nonfederal contract, a federal grant award, a federal contract, or an industry-sponsored study.
The preaward financial process entails the following:
- A clinical research study is proposed, either by an industry sponsor or via a grant application.
- Using study documents, including the protocol, draft budget, and the contract (if available) a study budget and billing grid is created. Once approved, the applicable information is maintained in the Clinical Research Management System and the study is then created in Epic Research.
- Study agreement(s) are completed, or a notice of award is received.
- Research Finance Operations creates the study account in PeopleSoft upon receiving the award authorization from Sponsored Programs Administration or the request for account setup from the Clinical Research Support Unit.
The postaward financial process entails the following:
- The study team monitors study expenses and enrollment activity, scheduled visits, study milestones, and invoiced activities, and informs Research Finance Operations and the Clinical Research Support Unit via email at email@example.com once milestones have been met or invoiced activities have occurred.
- The Clinical Research Support Unit works with Research Finance Operations to create study invoices and recognize clinical trials revenue within PeopleSoft. When all study activities have been completed, the study is closed with the Institutional Review Board by the study team.
- The study team works with Clinical Research Support Unit finance experts to ensure billing and final payments are completed appropriately. Upon agreement and receipt of final payment, a closeout form is completed and submitted to Research Finance Operations.
- Clinical Research Support Unit reconciles the account and evaluates remaining balances.
- The project is closed out in financial systems and any residual balance is distributed per intuitional and department policy.