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Protocol Navigator (NCI)

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Job Number:
647867
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 investigators and other research staff with direct support for the development of National Heart, Lung, and Blood Institute (NHLBI) intramural clinical research protocols consistent with policies that govern human subject’s research.

KEY ROLES/RESPONSIBILITIES

The Protocol Navigator:

  • Orchestrates meetings with investigators and other key medical staff to identify required support
  • Works directly with investigators and study team members on the production and revision of clinical research protocols and Informed Consent Forms (ICFs), and facilitates the activities of writing and regulatory review with bi-directional dialogue and feedback
  • Assists the research study team with Investigational New Drug (IND)/Investigational Device Exemption (IDE) development and serial submissions to the U.S. Food and Drug Administration (FDA); assists research staff in navigating requirements for special circumstances
  • Facilitates the process to obtain required approvals to initiate intramural research
  • Coordinates with investigators and study team members to ensure stipulations from approving bodies (scientific review, Institutional Review Board [IRB] and radiation safety) are addressed appropriately and in a timely manner
  • Provides consultation and assistance to complete protocol lifecycle requirements (e.g., continuing review applications, bioethics reviews, protocol amendments, applicable Data Safety Monitoring Board [DSMB] reviews), FDA Annual Reports, regulatory binder maintenance)
  • Ensures activities are conducted in a timely manner and in accordance with NIH policies and guidelines, as well as applicable IND/IDE regulatory guidelines
  • Facilitates establishment of Clinical Trial Agreement (CTA) and Materials Transfer Agreements (MTAs) with the Office of Technology Transfer
  • Tracks the required approvals necessary to initiate intramural research
  • Assists research staff in navigating requirements from various NIH departments for research collaboration approvals
  • Maintains up-to-date records of workload in available task tracking databases
  • Maintains study regulatory binders and interacts with internal and external monitors and auditors to ensure all regulatory documents are up-to-date
  • Attends onsite in-person meetings
  • Keeps current with the latest developments in human subjects’ research protection regulations and bioethics policies, informing NHLBI staff, as applicable


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/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
  • A minimum of five (5) years of progressively responsible experience in biomedical research, including four (4) years directly related to overseeing multiple concurrent trials
  • Must be proficient in all functions of clinical research implementation processes and conduct
  • Ability to work in a clinical research setting both independently and within a team to coordinate, negotiate, and facilitate data and ensure documents are succinct
  • Knowledge of regulatory requirements and guidelines for facilitating clinical human subjects research (including Department of Health and Human Services [DHHS] regulations)
  • Familiarity with protocol and informed consent documents and approvals needed to initiate a study
  • 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
  • Proficiency in Microsoft Office
  • Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
  • Ability to communicate effectively, orally and in writing, with non-technical and technical staff
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Familiarity with FDA regulatory requirements for IND and IDE; preferably those related to investigational biologic agents regulated by the FDA, and guidelines for facilitating clinical human subjects research
  • Heart, Lung, and Blood diseases experience
  • Knowledge of International Conference on Harmonization/Good Clinical Practices and DHHS regulations
  • Experience with the development of protocols including formatting and preparation, ICFs, and study monitoring plans
  • Knowledge of clinical trial design
  • Navigation of protocol life cycle experience


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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