Budget Coverage Analyst, Clinical Research Operations Office - Georgetown University Medical Center

  • Georgetown University
  • Washington, DC, USA
  • Nov 08, 2021
Full time Business/Financial Affairs/Financial Aid

Job Description

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Budget Coverage Analyst, Clinical Research Operations Office - Georgetown University Medical Center

Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.

The Budget and Coverage 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. They negotiate and compile clinical research budgets and review payment terms for clinical research projects that include unique and/or complex proposals, awards and contracts; and provide insight and direction to post award analysts related to invoicing ·and managing clinical research awards at Georgetown University Medical Center (GUMC), MedStar Health Research Institute (MHRI), MedStar Georgetown University Hospital (MGUH), and other MedStar entities as appropriate.

 

Reporting to the CROO Director, and interacting with CROO colleagues, study teams, and Principal Investigators, the Budget and Coverage Analyst has duties that include but are not limited to:

 

Budget Negotiation Negotiate budgets with sponsor and according to Fair Market Value and within the Georgetown policy and scope, ensuring that clinical research budgets are built correctly prior to release in the Clinical Trials Management System OnCore:

  • Reach 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 or 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.
  • Determine and document the correct allocation of clinical research supplies and services between routine (standard of care vs Research care) costs for billing justification and documentation – including time and effort by PI and CRCs.
  • Establish the protocol budget and payment terms with sponsors and/or funding entities in collaboration with GU Contract Manager.
  • Determine whether proposed clinical projects are a qualifying clinical trial (QCT) as defined by Medicare Clinical Trial Policy and relevant Local and National Coverage Decisions.

 

Medicare Compliance Ensure clinical research expenses are set to invoice in compliance with Medicare guidelines, per the original protocol:

  • Ensure that all research costs are allowable, per Medicare regulations (CMS).
  • Obtain and document stakeholder agreement to budgeting documentation, payer documentation, and routine (standard of care) vs research (protocol) cost documentation.
  • Provide clarification and direction to post award and other financial analysts regarding the budget invoicing and financial management of clinical research funds.

 

Clinical Trial Expenses Support the consistent and correct invoicing and billing of all clinical trial expenses per the original protocol:

  • Distribute approved protocol budgets to all stakeholders at GUMC, MHRI and MGUH.
  • Obtain and document stakeholder agreement to billing of expenses as routine (standard of care) vs research (protocol) in advance of protocol initiation.
  • Provide documentation and billing data on routine (standard of care) vs research (protocol) costs to all stakeholders at GUMC, MHRI and MGUH prior to service to ensure accuracy.
  • Obtain and document corrections when needed.

 

 

Preferred and Required Qualifications

Qualifications

  • Bachelor's degree related to health care or business
  • 5 to 7 years of experience in related field – with 2 years’ of experience in clinical trials budgets in a hospital, university, or academic medical center settings

 

Preferred qualifications

  • Direct experience with budgeting oncology or non-oncology clinical trials, Medicare coverage analysis, and research finance
  • Experience with Clinical Trials Management System (Encore) and ability to input trials and budgets into system
  • Experience in Oncology

Application Details

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