As a Clinical Research Budget Coordinator I (Research Billing Specialist), you will be responsible for the oversight and management of post award billing and payment management of clinical trial budgets for industry, National Institutes of Health (NIH), and investigator-initiated clinical research. You will evaluate and interpret sponsor agreements and funding agency regulations and procedures to ensure timely, accurate, and compliant billing. Responsible for invoicing sponsors for the lifecycle of the study/award, verification of reimbursement to ancillary departments, and payment tracking and reconciliation at the study/visit level. Will ensure data integrity and accuracy of billing/payment information withing the Clinical Trial Management System (OnCore) and applicable subsystems such as CSMC financial system (PeopleSoft). Will act a liaison between the Principal Investigator/Department Study Team, sponsor, general accounting and the Office of Research Administration (ORA) for any customer service requests and follow up questions. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Primary duties and responsibilities:
Working under the general supervision of the Manager of Post Award Reporting and Compliance and OnCore Team Lead, responsible for the oversight and management of assigned portfolio of clinical trials under general research.
Manages sponsor billing and payments, reviews transactions and expenditures at the study level and review and guidance is focused on sponsor and agency requirements.
Conducts review, analysis and monitors study accounts to evaluate that cost expenses/details are appropriate and within expected limits according to budget. Works closely with investigators, study teams and ORA OnCore Administrator to ensure accurate and timely entry of occurred/completed visits according to the visit calendar.
May conduct review and/or audits of clinical trial budget. Serves as a resource for fiscal related questions.
Responsible for invoicing sponsors from start-up related costs, protocol-related items, patient research billing, withholding and closeout related fees within OnCore as per the executed contract or award.
Works closely with sponsors and clinical teams to resolve queries regarding invoices and/or payments due.
Works with Clinical Trial Administration Office (CTAO) Budget Officers to assist with the interpretation of budget entries within OnCore in order to streamline and optimize sponsor billing.
Responsible for tracking and application of sponsor payments along with reconciliation of payments at the visit level within OnCore. Follows up with sponsors and/or clinical teams regarding outstanding payments.
Acts a liaison with Post Award Analyst and Finance to resolve any discrepancies in payment application.
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.
Reviews, analyze and resolves issues related to subsystem integration.
Demonstrates flexibility and initiative to effectively support change efforts to respond to environmental and organizational changes.
Establishes effective working relationships with cross-functional team(s).
Identifies and responds appropriately to both internal and external customer needs utilizing available resources.
Represents the company with external constituents.
Responds timely, effectively and appropriately to deliverables.
Minimum High School Diploma/GED is required
Bachelor's Degree Accounting, Finance, or other related degree is highly preferred
Minimum of two (2) years experience with billing, accounting, finance, budgeting, financial analysis or related field
At least one (1+) years experience with OnCore (CTMS Enterprise Research System) centrailized billing.
Minimum three (3) years Pre and/or Post Grant and Contract Funding experience in clinical research preferred
Licenses & Certifications:
Certification In Clinical Research preferred
Budgetary & Financial - Ability to apply knowledge of accounting principles to create, monitor or operate to budget(s).
Communication - Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
Communication - Ability to influence and/or negotiate.
Regulatory - Ability to use discretion and maintain privacy, confidentiality or anonymity Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Regulatory - Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines.
Technical - Ability to use software applications and operate technological devices (e.g., computer, laptop, tablet, smartphone, etc.) Uses various software applications, such as spreadsheets, relational databases, statistical packages, and graphics packages to assemble, manipulate and/or format data and/or reports.
Time Management - Ability to work within tight timeframes and meet strict deadlines.
Time Management - Ability to handle multiple demands and/or manage complex and competing priorities.
Working Title: Clinical Research Billing Specialist (Budget Coordinator I) - Office of Research Administration
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.