Manager/Clinical Trials Budget and Coverage Analyst, Clinical Research Operations Office - Georgeto

Location
Washington D.C.
Posted
Jul 03, 2018
Closes
Jul 31, 2018
Function
Analyst, Management
Industry
Research
Hours
Full Time
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.

Requirements

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:

Budget Negotiation

  • 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.

Requirements

  • 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

Current Georgetown Employees:

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Submission Guidelines:

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.

Need Assistance:

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 ideaa@georgetown.edu.

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.

EEO Statement:

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.

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