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Clinical Budget Analyst III - Ebola Research

Job ID: req1616
Employee Type: exempt full-time
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides support to the financial management and oversight of NIAID DCR’s clinical research studies, including Ebola, HIV, COVID and other clinical research studies. The position will compile and assist with the analysis of financial information for clinical research efforts supported within the program. 

KEY ROLES/RESPONSIBILITIES

  • This position is in direct support of the Ebola clinical research projects in Africa, to include all financial aspects and detailed subcontractor management
  • Gathers, analyzes, prepares and summarizes recommendations for financial plans, acquisition activity, trending future requirements, operating forecasts, etc.
  • Monitors and provides monthly expense analyses on complex projects/problems in which analysis of situations or data requires an evaluation of tangible and intangible variables
  • Works with the Business Analyst IV, primary program managers and clinical research teams to develop internal budgets that include all projected costs applicable to the clinical research studies and projects
  • Develops detailed final budgets, in conjunction with the supervisor and project teams, identifying all clinical research activities, tests, and other associated activities to be performed during the conduct of the study based on the study protocol and related documents
  • Works closely with partner organizations, including subcontractors, to ensure final project/study budgets are adhered to and updated when necessary, following appropriate steps for review and approval
  • Assists with performing financial forecasting and reconciliation of internal accounts
  • Prepares, monitors and analyzes cost proposals, reports and staffing for review by the supervisor and/or project team
  • Oversees subcontractor budgets and cost proposals in support of CMRPD’s Ebola research in Africa.
  • Prepares closing financial reports and obtains proper approvals from program management
  • Maintains annual budget assumption documents with up-to-date information to track for actuals, approvals and estimates at completion details
  • Maintains and tracks protocol budget documentation and conducts regular audits to ensure the accuracy and completeness of these records
  • Assignments may be performed independently with the support of program management staff or in conjunction with other Business Analysts within CMRPD
  • Works with supervisor on complex clinical research studies where analysis requires an in-depth evaluation of variable factors
  • This position is located in Frederick, Maryland

BASIC QUALIFICATIONS

  • Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to the education requirements, a minimum of five (5) years progressively responsible job-related experience
  • Progressively responsible experience must demonstrate increased independence and overall responsibility for more complex projects
  • Demonstrated experience with analysis of budgets and costs, including burn rates and cost projections
  • Demonstrated ability of budget building and cost tracking
  • Ability to collect and disseminate information in a clear, concise manner
  • Ability to create Excel and database reports
  • Ability to track multiple projects concurrently
  • Advanced knowledge of MS Office Suite including Excel (advanced), PowerPoint (advanced), and Word (intermediate)
  • Excellent research and investigative skills with a high degree of accuracy and attention to detail
  • Ability to review complex documents independently and/or in collaboration with clinical research managers, and determine sufficiency of financial documentation
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Experience working with the U.S. Government or as a Government Contractor
  • Knowledge of governmental regulations; working knowledge of the FAR/FTR
  • Budgetary and strategic planning experience and responsibilities as it relates to clinical research
  • Knowledge of study design, clinical and biospecimen terms used in research studies and scientific and medical concepts and terminology
  • Master’s Degee in Business Administration or related field
  • Experience with ERP systems, especially IBM Cognos, Costpoint and Focuspoint

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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