Come join our team!

The Clinical Research Finance Coordinator I develops clinical trial budgets for industry, National Institutes of Health (NIH), and investigator-initiated clinical research. Evaluates research protocols to assess resource needs for research procedures, clinical research staff time, investigator time, and costs from ancillary departments. Identifies cost allocation, negotiates budgets, details budgets, and responsible for monitoring accounts and invoicing. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

What are the primary duties & responsibilities for this role?

• Work closely with investigators and ancillary departments to identify research procedures needed, budget estimates and cost details.
• Evaluate research protocols to assess resource needs, procedures, clinical research staff time, investigator time, and costs from ancillary departments. Process Ancillary Agreements with departments providing research services.
• Identify and/or research whether research procedures in the protocol are standard-of-care or a research-related costs in order to correctly classify expenses.
• Develop clinical trial budgets for industry, National Institutes of Health (NIH), and investigator-initiated sponsored clinical research. Work with the CSMC office of Sponsored Research to develop final budgets for clinical trials and research projects.
• Negotiate trial budgets and payments with industry sponsors.
• Monitor study accounts to evaluate that cost expenses/details are appropriate and within expected limits, reconciles accounts receivable and payments, and identifies any deficits and/or surpluses. Negotiate with sponsors the final payment due for account closeout. May conduct review and/or audits of clinical trial budget. Serve as a resource for fiscal related questions.
• Responsible for invoicing sponsors, patient research billing, reimbursement to ancillary departments, and payment tracking. Issue and submit invoices for protocol-related items and patient-related expenses per the executed contract and internal invoices for staff time and effort allocation into study accounts. Work closely with sponsors and clinical teams to resolve queries regarding invoices and/or payments due.
• Extract information, analyzes and interprets data to determine financial performance and/or to project a financial probability. Prepare and deliver data, reports and/or presentations to investigators, management and/or leadership.
• Enter financial information from finalized clinical trial budgets and clinical trial agreements into the Clinical Trial Management System. Review and finalize clinical trials calendars to ensure agreement with Medicare coverage analysis and clinical trial budget.
• Perform Medicare coverage analysis for clinical trials and collaborates with Institutional Review Board (IRB) to finalize and obtain approval.
• Review protocol amendments for impact to sponsored research budget/contract. Process budget/contract amendments as applicable.

What are the department-specific duties for this role?

• May prepare and submit protocols, continuations/modifications, and related supporting documents to regulatory bodies such as the FDA, PPC, PRMC, IBCS (if needed), Cedars-Sinai IRB, Third Party IRB (WIRB) and any research committee involved in the Pre-Award/Post-award process.
• May generate or maintain reports, regulatory files, research files, REDCap databases, and general documentation to meet the needs or regulatory requirements for research projects.

Education, Experience & License/Certification Requirements:

• High School Diploma / GED required. Bachelor's Degree in Accounting, Finance, or other related degree preferred.
• One (1) year of experience with billing, accounting, finance, budgeting, financial analysis or related field preferred.
• Certification In Clinical Research preferred.

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