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Protocol Navigator (NCI)

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Job Number:
648717
Job Category:
Healthcare / Life Sciences / Medical
Location:
BETHESDA, MD US
Schedule:
Full-time
Travel:
None
Shift:
Day Job
Potential for Teleworking:
No
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
Public Trust
Description:

PROGRAM DESCRIPTION

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) 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 Institute of 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, CMRP’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. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health 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, CMRP services include comprehensive clinical trials, 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.  CMRP’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 (CMRP) provides protocol navigation and regulatory support to Phase I/II clinical trials being conducted by the National Institute of Health's (NIH’s) National Heart, Lung, and Blood Institute (NHLBI).

KEY ROLES/RESPONSIBILITIES

As part of the Protocol Navigation/Protocol Development Program (PN/PDP), the Protocol Navigator (PN) II:

  • Provides protocol development and implementation support for NHLBI’s intramural research protocols conducted domestically
  • Creates timelines based on the level of protocol navigation support needed and manages protocol start-up logistics
  • Works directly with Principal Investigators (PIs) and study team members on the preparation and revision of study documents and provides guidance during the regulatory review
  • Assists with the design, plan and implementation of clinical research, including protocols and informed consent forms (ICFs)
  • Works closely with the Institutional Review Board (IRB) office to keep abreast of new guidance related to protocol and informed consent submissions for both IRB initial reviews and amendments, and shares relevant information with PN/PDP team members
  • Ensures activities are conducted in a timely manner and in accordance with NIH policies and guidelines, as well as applicable Investigational New Drug/Investigational Device Exemption (IND/IDE) regulatory guidelines
  • Assists research staff in navigating requirements from various NIH departments for protocol approval and helps to identify services available at the NHLBI and the NIH
  • Serves as the point of contact for PIs on PN/PDP project assignments
  • Tracks the required approvals necessary to initiate intramural research
  • Provides consultation and assistance in completing protocol lifecycle requirements, amendments, Continuing Reviews, FDA Annual Reports, Ethics clearance, and regulatory binder maintenance
  • Coordinates with PIs and study team members to ensure stipulations from approving bodies (scientific review, IRB and radiation safety) are addressed appropriately and in a timely manner
  • Maintains up-to-date records of workload in available task tracking databases
  • Attends meetings in-person and provides meeting minutes

This position will be located in Bethesda, Maryland


Qualifications:

BASIC QUALIFICATIONS

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

  • Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research, clinical trials, health (Additional qualifying experience may be substituted for the required education); Foreign degrees must be evaluated for U.S. equivalency   
  • In addition to the educational requirements, a minimum of two (2) years of progressively responsible experience in biomedical research, including a minimum of one (1) year directly related to overseeing multiple concurrent projects
  • Must be proficient in all functions of clinical research implementation processes and conduct
  • Knowledge of regulatory requirements and guidelines for facilitating clinical human subjects research (including Department of Health and Human Services regulations)
  • Familiarity with protocol and informed consent documents and approvals needed to initiate a study
  • Ability to work in a clinical research setting, both independently and within a team, to coordinate, negotiate and facilitate program goals
  • Ability to prioritize multiple tasks and projects while establishing timelines, tracking milestones, and dealing with shifting priorities
  • Ability to submit quality products under tight deadlines
  • Ability to communicate effectively, both orally and in writing, with non-technical and technical staff
  • Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
  • Proficiency in Microsoft Office
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Familiarity with therapeutic area of heart, lung or blood diseases
  • Protocol development experience
  • Navigation of protocol life cycle experience
  • Knowledge of clinical trial design
  • Knowledge of International Conference on Harmonization/Good Clinical Practices


Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.
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