Manager of Clinical Trials / Budget & Coverage Analyst, Clinical Trial Research Operation
Manager of 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 generate 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; negotiates and compiles clinical research budgets and review payment terms for clinical research projects will include unique and/or complex proposals, awards and contracts; and 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. Reporting to the CROO Administrative Director, the Manager of Clinical Trials / Budget & Coverage Analyst has duties that 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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