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Clinical Budget Analyst II

Job ID: req1173
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 USA

The Frederick National Laboratory is dedicated to improving human health through discovery and innovation in the biomedical sciences, focusing on cancer, AIDS, and emerging infectious diseases. 

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 specialized support for initiatives and special projects in support of the National Institute of Allergy and Infectious Diseases (NIAID).  CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and other emerging infectious diseases.  This position will support the various initiatives and special projects of NIAID. 

 KEY ROLES/RESPONSIBILITIES

Responsibilities include but are not limited to:

  • Organizes and implements a variety of responsibilities related to the flow of materials, products, services and associated systems information
  • Performs technical analysis to determine present and future financial performance
  • Gathers, analyzes, prepares and summarizes recommendations for financial plans, acquisition activity, trended future requirements, operating forecasts, etc.
  • Coordinates to ensure that Task Orders are prepared, submitted, and tracked
  • 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 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 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
  • Identifies trends and developments in competitive environments and presents findings to senior management
  • Performs financial forecasting and reconciliation of internal accounts
  • Prepares, monitors, and analyzes cost proposals, reports and staffing
  • Reviews and approves costs related to new/proposed contracts, modifications/amendments and invoices for financial verification
  • 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
  • Communicates with director, senior management, program staff and NIAID DCR project officials to provide consistent and accurate information working closely with the Leidos Biomedical Research Finance team to ensure the production, change, update, or modification of various financial reports
  • Monitors program process flows and works in concert with the CMRP management team to accurately document and report project updates
  • Relies on experience and judgement to plan and accomplish goals
  • Maintains and tracks protocol budget documentation and conducts regular audits to ensure the accuracy and completeness of these records
  • Works independently to assess complex clinical research studies where analysis requires an in-depth evaluation of variable factors
  • This position will be located in Frederick, Maryland 

BASIC QUALIFICATIONS

  • Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation in a scientific discipline. (Additional qualifying experience may be substituted for the required education)
  • Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirements, a minimum of two (2) years progressively responsible job-related experience
  • Experience with analysis of budgets and costs, including burn rates and cost projections
  • Ability to perform budgeting and cost tracking
  • Ability to collect and disseminate information in a clear, concise manner
  • Ability to create and modify complex Excel and other database driven reports
  • Ability to track multiple projects concurrently
  • Working knowledge of MS Office Suite including Excel (advanced), PowerPoint (intermediate), 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
  • Must be able to obtain and maintain a security clearance 

PREFERRED QUALIFICATIONS

  • Knowledge of governmental regulations; knowledge of human subject’s protection and/or clinical research activities
  • Advanced knowledge of Microsoft Excel including use of pivot tables, writing complex formulas and shortcut knowledge
  • 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
  • Knowledge and experience working with government contracts/subcontracts