| Job Description: |
Pre-Award and Clinical Trial Administration:
Utilizing financial concepts, experience, and knowledge of clinical research, the incumbent will provide clinical
research financial services to the Clinical Trials Office and its affiliated members, as well as internal and external
partners. This will include:
- Lead proposal development, preparation, and submission for clinical trials, federal, state, and private
sponsors.
- Interpret funding announcements (RFPs, RFAs, FOAs) and ensure compliance with sponsor and
institutional guidelines
- Develop and negotiate grant and clinical trial budgets with industry sponsors and funding agencies.
- Coordinate pricing and effort with study teams and support units.
- Monitor study financial activity, including sponsor payments and subject-related costs.
- Manage Human Subject Payments (HSP), ensuring compliance with applicable regulations.
- Maintain financial systems (e.g., OnCore) and ensure accurate study setup, billing grids, and tracking logs.
- Perform financial reconciliation between clinical systems and institutional records
- Train study teams on clinical research financial processes.
- Submits new and amended clinical research projects to the Clinical Research Hub (CRH) and tracks CRH
reviews.
- Collaborates with CRH coverage analysis and budget team to confirm that studies meet the definition of a
Qualifying Clinical Trial, which study-related items/services may be considered to be Routine Costs, and
which items/services are allowable for Medicare reimbursement;
- Conducts quality assurance review of clinical research data maintained in OnCore, works with CRH to
correct inconsistencies;
- Maintains study tracking logs, monitors all study-funded services associated with the study, confirms that
all services performed have been charged to the appropriate payer (e.g. grant, sponsor, third-party payer),
confirms that all costs associated with the study have only been paid once.
- Collaborates with DSP contracting team to ensure contractual agreement is executed and any intellectual
property rights are protected.
- Coordinate proposal components (biosketches, other support, facilities, subawards, etc.) for completeness
and accuracy.
Post-Award and Financial Management:Manage post-award administration for grants, contracts, and clinical trials, including award setup, reconciliation, and closeout.
- Monitor financial performance, projections, and budget adherence; provide regular reporting to
PIs.
- Oversee expenditures to ensure they are allowable, allocable, and compliant with sponsor and
university policies.
- Manage payroll distributions, effort reporting, cost share, and financial transactions (transfers,
modifications, etc.).
- Track sponsor payments, invoicing, accruals, and financial activity for clinical trials.
- Reconcile accounts, resolve overdrafts, and support project closeouts.
- Maintain financial tracking tools and prepare detailed financial reports and projections.
- Coordinate agreements through institutional systems (e.g., UFIRST) and serve as liaison with
central offices.
- Track subaward payments and ensure adherence to contractual obligations.
- Creates and negotiates sub-site budgets for Investigator Initiated Trials (IITs) ensuring
compliance with prime award requirements.
- Works with CRH and DSP to create and negotiate master contracts and task orders with subsites;
- Manages payments to sub-sites per the negotiated contracts for IITs. Ensures sub-site invoices
are accurate and tracks all payments associated with each project.
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