Protocol Navigator II

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, 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. 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 CMRPD/Regulatory Compliance and Human Subjects Protection Program (RCHSPP) provides protocol navigation support to the National Institute of Allergy and Infectious Diseases (NIAID) Intramural Clinical Research Community, Division of Clinical Research (DCR), Office of Clinical Research Policy and Regulatory Oversight (OCRPRO).

KEY ROLES/RESPONSIBILITIES

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

• Provides protocol development and implementation support for NIAID intramural research protocols conducted domestically and internationally
• Serves as the point-of-contact and project manager for an assigned portfolio of projects
• Orchestrates meetings with Principal Investigators (PIs) and other key research staff to identify the level of support needed, creating timelines and managing protocol start-up logistics
• Works directly with PIs and Medical Writers (MWs) on the design, plan, production and revision of study documents, including applying clinical and regulatory knowledge to the review of protocol and informed consent documents
• Ensures activities are conducted in a logical and timely manner and in accordance with policies and guidelines
• Assists research staff in navigating requirements for protocol approval: completes submissions to approving bodies (e.g., scientific review, IRB and radiation safety), coordinates with PIs and MWs to ensure stipulations are addressed appropriately and on-time, and tracks the required approvals necessary to initiate intramural research
• Provides advice and assistance in troubleshooting human subjects protection issues
• Works closely with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments, and to share relevant information with PN/PDP team members
• Collaborates and communicates with other divisions and individuals (Regulatory Affairs, the Clinical Safety Office and site monitors) to: identify the regulatory guidelines and required timelines for Food and Drug Administration (FDA) requisite activities; ensure protocol design safety issues are identified early; ensure required oversight is initiated and outlined in the protocol
• Performs work independently under the general guidance of the supervisor
• Attends virtual and in-person meetings at the NIH campus in Bethesda, Maryland
• This position is located in Rockville, Maryland, telework during COVID-19 restrictions