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Sr. Program Coordinator - COVID-19

Job ID: req1149
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, tuberculosis, malaria and other infectious diseases and viruses such as hepatitis C 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) Division of Clinical Research (DCR).  CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and possibly other emerging infectious disease studies globally.  All or a portion of these research studies will be coordinated through a Clinical Research Organization (CRO).  

KEY ROLES/RESPONSIBILITIES

Responsibilities include but are not limited to:

  • Provides support to various designated high-profile clinical research projects related to COVID-19 and other possible emerging infections disease studies
  • Provides administrative and programmatic support including planning, research, analysis and correspondence for the project(s)
  • Evaluates project related supply requests and obtains appropriate approvals for items to include, but not limited to; laboratory/research equipment/supplies, office supplies, and other operational supplies
  • Oversees inventory logistics management (delivery and receipt), working with subcontractors, NIAID and CMRPD staff to process and track procurement/purchasing requests per established Federal Acquisition Regulations (FAR)
  • Drafts vendor justifications, reviews vendor invoices and monitors adherence to budgets, and coordinates shipping and tracking of related procurements
  • Works with cold chain shippers to set-up online portals for research sites, monitor shipment orders through to delivery, tracks orders and related information for invoice processing
  • Researches and manages high-level equipment procurement requirements, trainings, and service maintenance agreements
  • Communicates and interacts with high-level executive, administrative, technical and program management staff, both internally and externally, to gather and compile information for dissemination
  • Maintains various tracking systems using Microsoft Excel, Microsoft Visio, Smartsheet, SharePoint and other applicable project and program related software
  • Assists in the collection and compilation of metrics data and operational accomplishments in support of Leidos Biomed reporting requirements
  • Arranges and coordinates scientific meetings, seminars and conferences, including logistical matters such as locations, times, participants, agendas and schedules
  • Draft process documents and process flows for project team
  • Manages central document archive for study-related and subcontract-related documents
  • Oversees complex domestic and international travel logistics and arrangements per established Federal Travel Regulations (FTR)
  • Prepares and/or assembles presentations, background information and related materials and information for meetings
  • Prepares internal and external correspondence and memos, and transcribes and edits meeting minutes for final review
  • Coordinates conference room scheduling/logistics and calendars for staff
  • Position is located in Frederick, Maryland 

BASIC QUALIFICATIONS

  • Possession of a Bachelor's degree from an accredited college/ university according to the Council for Higher Education Accreditation (CHEA) in biomedical/clinical research/healthcare or four (4) years related experience in lieu of degree
  • Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirements, five (5) years of progressively responsible administrative experience
  • Ability to perform and organize administrative processes to effectively and efficiently manage daily operations and coordinate program planning
  • Strong organizational skills with the ability to prioritize multiple tasks and projects
  • Experience in procurement acquisition, shipping and inventory management
  • Proficiency in Microsoft Office software (Word, Outlook, Excel, Visio and PowerPoint)
  • Excellent verbal and written communication skills
  • International clinical research project support experience
  • Familiarity with Federal Acquisition Regulations (FAR), Federal Travel Regulations (FTR), Department of Transportation (DOT) and International Air Transport Association (IATA) shipping regulations
  • Flexibility and willingness to adapt in a changing environment
  • Possesses knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
  • Knowledge of clinical trial fieldwork concepts and practices, specifically international clinical research guidelines related to site management requirements
  • Must be able to obtain and maintain a security clearance 

PREFERRED QUALIFICATIONS

  • Clinical Research or Project Management Professional with infectious disease experience
  • Familiarity with the management of study products and supplies, experience conducting federally funded research studies, experience in overseeing the work of subcontractors and/or vendors
  • Health science or laboratory experience, particularly in infectious disease
  • Knowledge of Microsoft Project or other project tracking software

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

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