Cedars-Sinai is seeking a Clinical Research Finance Coordinator II (Pre-Award) to join our dynamic research team. In this role, you will be responsible for the financial management of clinical research studies during the pre-award phase. You will collaborate with principal investigators and study teams to develop and negotiate budgets, review contracts, and ensure compliance with institutional and sponsor regulations. This position requires strong attention to detail and expertise in research finance to support the successful launch of clinical studies.

The Clinical Research Budget Coordinator II develops complex clinical trial budgets for industry, National Institutes of Health (NIH), and investigator-initiated clinical research. Evaluates research protocols to assess resource needs, procedures, clinical research staff time, investigator time, and costs from ancillary departments. Determines 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.

Primary Duties and Responsibilities:

• Works closely with investigators and ancillary departments to identify research procedures needed, budget estimates and cost details.
• Evaluates complex research protocols to assess resource needs, research procedures, clinical research staff time, investigator time, and costs from ancillary departments.
• Determines whether research procedures in the protocol are standard-of-care or a research-related costs in order to correctly classify expenses.
• Develops complex clinical trial budgets for industry and the National Institutes of Health (NIH) as well as investigator-initiated clinical research. Works with the CSMC office of Sponsored Research to develop final budgets for clinical trials and research projects.
• Negotiates trial budgets and payment terms with industry sponsors.
• Monitors study accounts to evaluate the cost expenses/details are appropriate and within expected limits, reconciles accounts receivable and payments, and recommends the best course of action for any deficits and/or surpluses. Negotiates with sponsors the final payment due for account closeout. May conduct review and/or audits of clinical trial budgets. Serves as a resource for fiscal related questions and engages management as appropriate.
• Responsible for invoicing sponsors, patient research billing, reimbursement to ancillary departments, and payment tracking. Issues and submits 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. Works with sponsors and clinical teams to resolve queries regarding invoices and/or payments due.
• Extracts and defines relevant information, analyzes and interprets data to determine financial performance and/or to project a financial probability and makes recommendations to influence business results. Prepares and delivers data, reports and/or presentations to investigators, management and/or leadership.
• Enters financial information from finalized clinical trials budgets and clinical trial agreements into the Clinical Trial Management System. Reviews and finalizes clinical trials calendars to ensure agreement with Medicare coverage analysis and clinical trial budget.
• Performs Medicare coverage analysis for clinical trials and collaborates with Institutional Review Board (IRB) to finalize and obtain approval.
• Reviews protocol amendments for impact to sponsored research budget/contract. Process budget/contract amendments as applicable.
• May provide training and education to other personnel.
• May plan and coordinate strategies to improve existing standard operating procedures related to budgeting and clinical trials finance. May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.

Requirements:

To be considered for the Clinical Research Finance Coordinator II (Pre-Award) position, applicants must have direct experience in a clinical research setting. This role requires a understanding of the financial aspects of clinical trials, including budget preparation, funding management, and financial reporting, all within the context of research projects. Applicants should have hands-on experience in pre-award processes, such as the preparation of grant proposals, contract negotiations, and coordination with internal and external stakeholders to ensure compliance with funding requirements. Prior experience working within a clinical research environment is essential to effectively manage the complexities of this role.

• High School Diploma or equivalent experience/GED required. Bachelor's Degree Accounting, Finance, or other related degree preferred.
• Minimum of 3 years of experience with billing, accounting, finance, budgeting, financial analysis or related field.
• Minimum of 1 year of experience in clinical research.

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