Manager/Clinical Trials Budget and Coverage Analyst, Clinical Research Operations Office - Georgeto
Manager/Clinical Trials Budget and Coverage Analyst, Clinical Research Operations Office - Georgetown University Medical Center
The mission of Georgetown's Clinical Research Operations Office (CROO) is to provide services to: ● Georgetown researchers, assisting with study start-up and administration; ● Patients and the general public, providing up-to-date information about ongoing clinical studies at Georgetown University Hospital Medical Center (GUMC); ● and Sponsors, helping them identify GU investigators for participation in their research.
The Manager/Clinical Trials and Budget Coverage Analyst provides analytical support for the more complex budget projects primarily for clinical research funded by private industry funding sources. S/he reviews and audits proposed department budgets; coordinates all submissions into a united budget and financial forecast; monitors current budget and reviews proposed budget control procedures to determine necessary improvements; issues budget variance reports and follows up on remedial actions; and as needed, provides functional advice or training to less-experienced budget analysts.
The Manager/Analyst generates clinical research billing plans and Medicare Coverage Analyses (MCA) for all industry sponsored studies; and ensures budgeting/expense/coverage consistency across GU clinical trials documentation, including the protocol, informed consent(s), and budget and contract payment terms.
The Manager/Analyst negotiates and compiles clinical research budgets and review payment terms for research projects that include unique and/or complex proposals, awards and contracts. S/he provides insight and direction to post award analysts regarding invoicing ·and managing clinical research awards at Georgetown University Medical Center (GUMC), MedStar Health Research Institute (MHRJ), Georgetown-MedStar University Hospital (GUH), and other MedStar entities as appropriate.
Reporting to the Administrative Director of Clinical Research Operations, the Manager/Analyst has duties that include but are not limited to:
- Negotiates budgets with sponsor and according to Fair Market Value and within the Georgetown policy and scope.
- Ensures that clinical research budgets are built correctly prior to release in the Clinical Trial Management System (OnCore).
- Reaches out to the sponsor in a timely manner to start budget negotiations for each clinical trial.
- Reviews entire schedule of events and budgets for clinical research protocols with clinical research coordinators and principal investigators, and other team members as needed/recommended before the study is released in OnCore and commences.
- Maintains study updates on the Georgetown Dashboard/CTMS on negotiations with the sponsor and confers with PI or study teams as necessary.
- Determines and documents the correct allocation of clinical research supplies and services between routine (standard of care vs. Research care) costs for billing justification and documentation - including PI & CRC time and effort.
- Establishes the protocol budget and payment terms with sponsors and or funding entities in collaboration with GU contract manager.
- Determines whether proposed clinical projects are a qualifying clinical trial (QCT) as defined by Medicare Clinical Trial Policy and relevant Local and National Coverage Decisions.
- Completes billing designation for each item in OnCore.
Clinical Research Expenses
- Ensures clinical research expenses are set to invoice in compliance with Medicare guidelines, per the original protocol and amendments to that protocol as it moves forward.
- Ensures that all research costs are allowable per Medicare regulations (CMS).
- Obtains and documents in OnCore and other internal documents justifications LCDs and NCDs by citing policy numbers and the like.
Management Systems Compliance
- Assures compliant use of OnCore and contract management system (GUPASS) in collaboration with study team.
- Enters studies calendar into OnCore and reviews with study team.
- Enters into study negotiations with sponsor and document in GUPASS.
- Completes Medicare Coverage Analyses in OnCore for each study with details and justifications enabling an audit-friendly review.
Clinical Trial Expenses
- Supports the consistent and correct invoicing and billing of all clinical trial expenses per the current protocol, including the original and updating with the protocol amendments.
- Obtains and documents stakeholder agreement to billing of expenses as routine vs. research care in advance of the protocol initiation.
- Maintains documentation of billing data on routine (standard of care) vs. Research (protocol) costs for stakeholders at GUMC and MedStar Georgetown Hospital (MGUH)
- Provides clarification and direction to post award and billing compliance analysts, financial analysts, Georgetown Management System (GMS - Workday) resources regarding the budgets, invoicing, and compliant financial management of clinical research funds.
- Bachelor's degree related to health care or business
- 3 years of experience in clinical trials budgets in a hospital, or university or Academic Medical Center settings
- Direct experience with budgeting oncology clinical trials, Medicare Coverage Analyses, and research finance
- Experience with Clinical Trial Management System (OnCore) and the ability to input trials and budgets into system
- Ability to effectively collaborate with multiple departments and work in a team environment
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