This role offers a fully remote work arrangement. Please note that applicants must be based in California to be considered for this opportunity

This position is a post-award role, meaning the incumbent will support sponsored research projects after funding has been awarded. Responsibilities include financial management and oversight of active grants and contracts, such as monitoring budgets and expenditures, ensuring compliance with sponsor and institutional policies, processing financial transactions, preparing financial reports, and partnering closely with investigators and research teams to support the ongoing fiscal health of awarded studies. This role does not focus on proposal development or grant submission activities.

The Clinical Research Finance Coordinator III develops highly 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 and invoicing. Plans and coordinates strategies for improving efficiency, action plans to improve quality, and training and education of personnel. 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 highly complex research protocols to assess resource needs, research procedures, clinical research staff time, investigator time, and costs from ancillary departments. Processes Ancillary Agreements with departments providing research services.
• Determines whether research procedures in the protocol are standard-of-care or a research-related cost in order to correctly classify expenses.
• Develops highly complex clinical trial budgets sponsored for industry and the National Institutes of Health (NIH), investigator-initiated clinical research. Works with the CSMC office of Sponsored Research to develop final budgets for clinical trials and research projects. Reviews and approves internal and/or satellite site budgets.
• Negotiates trial budgets and payment terms with industry sponsors.
• Monitors study accounts to evaluate that cost expenses/details are appropriate and within expected limits, reconciles accounts receivable and payments, and determines the best course of action for any deficits and/or surpluses. Negotiates with sponsors the final payment due for account closeout. Conducts quality review and/or audits of clinical trial budgets. Serves as point of contact 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 closely 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 and/or creates proposals to influence business results. Prepares and delivers data, reports and/or presentations to investigators, management and/or leadership.
• Enters financial information from finalized clinical trial budgets and clinical trial agreements into the Clinical Trial Management System. Reviews and finalizes study calendars to ensure agreement with Medicare coverage analysis and clinical trials 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. Processes budget/contract amendments as applicable.
• Provides training, education, onboarding and mentors other personnel.
• Plans and coordinates strategies to improve existing standard operating procedures related to budgeting and clinical trials finance. Identifies quality and performance improvement opportunities and work with management to lead the development of new (or improvement of existing) processes, policies or standard operating procedures. Assists with business software launches, implementation or optimization.
• May lead or facilitate team meetings.

Requirements:

• High School Diploma/GED.
• 5 years of Experience with billing, accounting, accounting, finance, financial analysis or related field.
• 2 years of Experience in clinical research.

Preferred:

• Bachelors in Accounting, Finance, or other related degree