Regulatory Associate I

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 regulatory affairs support to NIAID's Division of Clinical Research (DCR), Office of Clinical Research Policy and Regulatory Operations (OCRPRO). CMRPD Regulatory Affairs staff also provides regulatory support and guidance to researchers within NCATS, NINDS, and NIAMS.

KEY ROLES/RESPONSIBILITIES

Regulatory Associate I (RA I)

• Completes projects of limited scope and/or portions of larger projects
• Works with clinical investigators and other clinical staff
• Assists with coordination of activities pertaining to the compilation and submission of original Investigational New Drug (IND) applications for management and multi-disciplinary team review
• Requests, compiles, and reviews documentation for IND amendments, annual reports, safety reports, and other submissions required for the life-cycle maintenance of these applications
• Prepares and submits INDs and amendments to the Food and Drug Administration (FDA) using electronic Common Technical Document (eCTD) software
• Researches reports, regulations, guidelines, databases, internal policies, etc., as appropriate in response to regulatory inquiries from internal and external sources
• Collects and reviews study specific documentation for each protocol submitted under an IND
• Assists with preparation and/or updates of Investigator's Brochures at the request of the project manager or investigator as described in 21 CFR 312.23 (a) (5) using results of preclinical and clinical testing from reports, reprints and other data available from the investigator, developer, or pharmaceutical company
• Participates in multi-disciplinary review of clinical research study documents
• Program goals and objectives are reviewed with the supervisor
• This 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 a field related to biomedical research (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
• No experience required with a Bachelor's degree
• Biomedical research or clinically related experience may be substituted for the degree
• Ability to function independently within a team to build strong relationships with multiple groups
• General knowledge of clinical trial concepts, practices and project implementation
• Ability to communicate effectively, orally and in writing, with both non-technical and technical staff
• Detail-oriented and possesses strong organizational/planning skills and the ability to prioritize multiple tasks/projects
• Knowledge of FDA regulations, 21 CFR, and GCPs
• Fluency with Microsoft Office Suite
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• eCTD preparation and submission experience
• Previous experience or training in life sciences
• Some regulatory management in clinical trials

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