Come join our team!

The Clinical Research Budget 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?

• Working closely with investigators and ancillary departments, identifies research procedures needed, budget estimates and cost details. Processes Ancillary Agreements with departments providing research services.
• Identifies and/or researches whether research procedures in the protocol are standard-of-care or a research-related costs in order to correctly classify expenses.
• Works with the CSMC office of Sponsored Research to develop final budgets for clinical trials & research projects.
• Negotiates trial budgets and payments with industry sponsors.
• Monitors 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. Negotiates with sponsors the final payment due for account closeout. May conduct review and/or audits of clinical trial budget. Serves as a resource for fiscal related questions.
• 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 information, analyzes and interprets data to determine financial performance and/or to project a financial probability. Prepares and delivers data, reports and/or presentations to investigators, management and/or leadership.
• Enters financial information from finalized clinical trial budgets & 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 IRB to finalize and obtain approval.
• Establishes effective working relationships with cross-functional team(s) and represents the company with external constituents
• Identifies and responds appropriately to both internal and external customer needs utilizing available resources & responds timely, effectively and appropriately to deliverables
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law & research practices using Good Clinical Practice (GCP) guidelines

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:

• High School Diploma/GED required. Bachelor's Degree in Accounting, Finance, or other related degree preferred.

Certification:

• Certification in clinical research preferred

Experience:

• Two (2) years of experience with billing, accounting, finance, budgeting, financial analysis or related field required.
• Three (3) years of pre and/or post grant and contract funding experience in clinical research preferred.