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.RequirementsBudget Coverage Analyst, Clinical Research Operations Office - Georgetown University Medical Center
The mission of the Georgetown University's Clinical Research Operations Office (CROO)
is to provide services to: Patients, by providing up-to-date information about ongoing clinical studies at Georgetown University Medical Center (GUMC); Sponsors, by helping them identify Georgetown University investigators for participation in their research; and Georgetown researchers, by assisting with study start-up and administration in pre- and post-award.
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.
- 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
- 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
Current Georgetown Employees:
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Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.
If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or [email protected].
Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.
Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law.
Georgetown University offers a wide variety of comprehensive and competitive benefits. Benefits packages include comprehensive health, dental and vision plans, disability and life insurance coverage, retirement savings programs, tuition assistance, voluntary insurance options (including group legal, accident, and critical illness), and much more. Whatever your need, the Office of Faculty and Staff Benefits will be standing by to support you. You can learn more about the benefits offered to eligible faculty and staff at https://benefits.georgetown.edu or view the online interactive benefits guide for more information.
To apply, visit https://apptrkr.com/2543521
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