Clinical Program Manager I

Clinical Program Manager I

Job ID: req3552
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 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.

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH.  

CMRPD’s ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD’s support services are aligned with the program’s mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides clinical program administrative support to the clinics operated by the Office of the Clinical Director (OCD), Center for Cancer Research (CCR), National Cancer Institute (NCI) at the National Institutes of Health (NIH).

KEY ROLES/RESPONSIBILITIES

• Assists in planning and development of educational and preventive outreach programs, research analysis, and correspondence control for special assigned projects
• Assists in production, reviews, and/or manages progress reports, special reports, quantitative and qualitative data driven documents, meeting reports, website content, patient surveys, and other planning and budget documents
• Assists in the preparation and planning necessary for the conduct of workshops and meetings of various topics and structure including the facilitation of training and communications
• Assists with coordination of meetings and site visits among various groups (government officials, NIH, LBR, etc.) to develop effective programs
• Attends meetings and participate in conference calls reviewing evaluation data and deliverables
• Hires, trains, develops, and appraises staff effectively
• Assists with preparation of progress and program reports, special reports, and planning and budget documents
• Assists with producing consensus reports, special journal issues, book projects, quantitative and qualitative data driven documents, meeting reports, monographs, bibliographies, website content, research guides, fact sheets, brochures, and other documents
• Coordinates the development of project management plans and monitors all aspects of project execution assisting in the creation of work breakdown structure, flow charts, and other presentations of process flow and organizational structures
• Interfaces and collaborates with members’ subcommittees, assisting with the development of presentation materials and project updates for Senior Management
• Performs overall programmatic administrative support for a wide variety of progressively more complex intramural research activities such as dealing with multifaceted problems where considerable judgment and initiative are required in resolving problems and making process flows and organizational recommendations
• Recommends new organizational systems and processes to make improvements in support systems for clinical research as well as assist in the creation and rollout of Project Management support systems for a variety of clinical research initiatives
• Processes improvement and efficiency in partnership with Assistant Director for Clinical Operations, examples include patient travel exceptions/other related exceptions needing automated solutions, medical credentialing, management of agreements and collaborative partnerships with other NIH areas
• Power BI/other database support
  • Clinical support staffing
  • Clinical trial accruals
• Support to special initiatives:
  • Retreat planning
  • Liaison with Clinical Center points of contact to streamline information and processes
• Management of CRADA budget requests
  • Initial information gathering
  • Organization and dissemination of information to OCD leadership for review and approval
  • Correspondence with PI
  • Tracking of finalized budgets
• Data collection and analysis
  • Clinical trials
  • Patient accruals
  • Patient travel and housing
• Oversight of outside medical services
  • Process improvement
  • Coordination of teams/vendors/purchasing
• OCD website management
  • Email and minutes archives
  • 508 compliances
  • OEC training modules
  • Conversion of current wiki to future CCR web migration
• Regular/periodic tasks:
  • Confidentiality agreement monitoring
  • Annual CRIS users audit
  • Budget justification requests   
• This position is located in Bethesda, Maryland

• BASIC QUALIFICATIONS

• Possession of a bachelor's degree from an accredited college/university with course work related to clinical sciences or four (4) years related experience in lieu of degree
• Foreign degrees must be evaluated for U.S. equivalency
• In addition to educational requirements, a minimum of two (2) years of responsible administrative experience in a hospital or medical environment, including one (1) year in a supervisory capacity
• Experience should include work with protocols, clinical site management, data collection and analysis
• Must possess general knowledge of clinical trial fieldwork concepts and practices, regulatory requirements and guidelines for clinical research and monitoring requirements
• Must be well versed in Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
• Must be able to perform project management-type tasks for multiple clinical research protocols
• Must be able to obtain and maintain a clearance

• PREFERRED QUALIFICATIONS

• Familiarity with State Department Regulations and FARs

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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