Business Analyst II / Clinical Finance (Local/Remote)

Job ID: req3490
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAMDESCRIPTION

WithinLeidos Biomedical Research Inc., the Clinical Monitoring Research ProgramDirectorate (CMRPD) provides high-quality comprehensive and strategicoperational support to the high-profile domestic and international clinicalresearch initiatives of the National Cancer Institute (NCI), National Instituteof Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart,Lung and Blood Institute (NHLBI), National Institute of Arthritis andMusculoskeletal and Skin Diseases (NIAMS), National Center for AdvancingTranslational Sciences (NCATS), National Institute of Neurological Disordersand Stroke (NINDS), and the National Institute of Mental Health (NIMH). Sinceits inception in 2001, CMRPD’s abilityto provide rapid responses, high-quality solutions, and to recruit and retainexperts with a variety of backgrounds to meet the growing research portfoliosof NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has ledto the considerable expansion of the program and its repertoire of support services. CMRPD’ssupport services are strategically aligned with the program’s mission to provide comprehensive, dedicated supportto assist National Institutes of Health(NIH) researchers in providing the highest quality of clinical research incompliance with applicable regulations and guidelines, maintaining dataintegrity, and protecting human subjects. For the scientific advancement ofclinical research, CMRPD services include comprehensive clinical trialsmonitoring, regulatory, pharmacovigilance, protocol navigation and development,and programmatic and project management support for facilitating the conduct of400 Phase I, II, and III domestic and international trials on a yearly basis.These trials investigate the prevention, diagnosis, treatment of, and therapiesfor cancer, influenza, HIV, and other infectious diseases and viruses such ashepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blooddiseases and conditions; parasitic infections; rheumatic and inflammatorydiseases; and rare and neglected diseases. CMRPD’s collaborative approach to clinical research and the expertise anddedication of staff to the continuation and success of the program’s mission has contributed to improving the overallstandards of public health on a global scale.
The Clinical Monitoring Research ProgramDirectorate (CMRPD) provides specialized support for initiatives and specialprojects in support of the National Institute of Allergy and InfectiousDiseases (NIAID). CMRPD is responsiblefor the management and oversight of NIAID clinical research studies related toCOVID-19 and other emerging infectious diseases. This position will support the various initiativesand special projects of NIAID. 

**Position is located in Frederick, Maryland.
KEYROLES/RESPONSIBILITIES

• 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
• 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

BASICQUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a BS degree from an accredited college or university (according to CHEA). (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 three (3) 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 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
• Ability to obtain and maintain a security clearance

PREFERREDQUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• 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

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