Manager Clinical Trials Budget & Coverage Analyst, Clinical Trial Research Operations - Georgetown
Manager Clinical Trials Budget & Coverage Analyst, Clinical Trial Research Operations - Georgetown University Medical Center
The mission of Georgetown University'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 Budget & Coverage Analyst generates clinical research billing plans and Medicare Coverage Analyses (MCA) for all industry sponsored studies. S/he ensures budgeting/expense/coverage consistency across GU clinical trial project documentation, including the protocol, informed consent(s), budget and contract payment terms, and negotiates and compiles clinical research budgets and review payment terms for clinical research projects will include unique and/or complex proposals, awards and contracts. S/he provides insight and direction to post award analysts related to invoicing and managing clinical research private industry awards at both GUMC, MedStar Health Research Institute (MHRI), Georgetown-MedStar University Hospital (GUH), and other MedStar entities as appropriate. Duties include but are not limited to:
- Ensures that all research costs are allowable, per Medicare regulations.
- Obtains and documents stakeholder agreement to budgeting documentation, pay or documentation, and routine (standard of care) vs. research (protocol) cost documentation.
- Provides clarification and direction to post award and other financial analysts regarding the budget, invoicing and financial management of clinical research funds.
Clinical Research Budgets
- Negotiates budgets with the sponsor according to Fair Market Value and within the Georgetown policy and scope; and ensures that clinical research budgets are built correctly prior to release in the Clinical Trials Management System (CTMS).
- Reaches out to the sponsor in a timely manner to start budget negotiations for each trial.
- Reviews entire schedule of events and budgets for clinical research protocols, in conjunction clinical research stakeholders such as PIs and CRCs before the study commences.
- Maintains updates on the Georgetown dashboard/CTMS on negotiations with the sponsors, and confers with PI or study team as needed with issues.
- Determines and documents the correct allocation of clinical research supplies and services between routine (standard or care) vs. research (protocol) costs for billing justification and documentation.
- Establishes the protocol budget and payment terms with sponsors and/or funding entities in collaboration with the Georgetown CROO contract manager.
- Determines whether proposed clinical projects are a qualifying clinical trial as defined by Medicare Clinical Trial Policy and relevant Local and National Coverage Decisions.
Consistent and Correct Invoicing
- Distributes approved protocol budgets to all stakeholders at GUMC, MHRI and GUH.
- Obtains and documents stakeholder agreement to billing of expenses as routine (standard of care) vs. research (protocol) in advance of protocol initiation.
- Provides documentation and billing data on routine (standard of care) vs. research (protocol) costs to all stakeholders at GUMC, MHRI and GUH prior to service.
- Provides clarification and direction to post award and other financial analysts regarding the budget, invoicing and financial management of clinical research funds; and obtains and documents corrections where needed.
- Bachelor's degree related to health care or business
- At least 3 years of experience in clinical trials budgets in a hospital, or university or Academic Medical Center settings
- Direct experience with budgeting clinical trials in both oncology and non-oncology, Medicare Coverage Analyses, and research finance
- Experience with Clinical Trials Management System (Encore) and ability to input trials and budgets into system
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