The Clinical Trial Budget Analyst is an integral member of the Clinical Research Operations team at Westchester Medical Center Health Network, in Hawthorne, NY. The position reports to the Director, Clinical Research Operations while supporting the hospital's greater clinical research initiatives and investigational community. This position is expected to perform detailed pre and post award reviews of clinical trial budget documents. S/he will independently evaluate this information to ensure research integrity and compliance with institutional policies, federal regulations, and Good Clinical Practice Guidelines.
Pre-Award:Reviews research applications for the following:
Identifies and documents a trial's qualification based on the CMS Clinical Trial Policy (Qualifying Clinical Trial determination).
Conducts a Coverage Analysis (CA) of all procedures, items, and/or services performed as part of the protocol to identify each as either Routine Care or Research.
Translates CA into a billing summary grid, which will specify appropriate billing codes that correspond to procedures outlined in the protocol.
Builds/reviews/updates billing trackers.
Post-Award: Conducts routine reconciliation of study trackers to ensure timely invoicing and proper billing practices. This includes
Drafting invoices to study team to cover Administrative Fees and to Sponsor for reimbursement of per patient cost and invoicable items.
Working with Hospital Patient Accounts and Private Practice patient Accounts to ensure research procedures are invoiced to the appropriate entity at the approved research rate.
Communicates relevant information and findings both verbally and through formal written reports. Presents findings to individuals, groups, and committees as required.
Provides guidance on corrective measures to address findings and education to investigators and all members of research staff.
Develop, update, implement and communicate changes to policies, forms, regulations and standard operating procedures.
Develops training materials and conducts regulatory training as needed. Maintains training records as required by regulations.
Performs other related duties incidental to the work described herein.
Minimum Job Requirements:
3-5 years' experience in clinical research, clinical operations/compliance, or billing compliance
Proficient in MS Excel
Invoicing experience preferred
Working knowledge of the Centers for Medicare and Medicaid Services (CMS) Clinical Trial Policy; medical terminology, medical billing, and/or billing compliance
Working knowledge of federal regulations related to clinical research, human subjects protection, and/or Good Clinical Practices
Works collaboratively with others
Possesses strong analytical, spreadsheet skills
Consistently communicates issues, resolves problems and suggests efficiencies
NorthEast Provider Solutions Inc. is an equal employment opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, sex, sexual orientation, gender identity, religion, disability, age, genetic information, veteran status, ancestry, or national or ethnic origin.