Clinical Safety 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 Clinical Monitoring Research Program Directorate (CMRPD) provides specialized support for initiatives and special projects in support of the National Institute of Allergy and Infectious Diseases (NIAID) Division of Clinical Research (DCR). CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and possibly other emerging and re-emerging infectious disease studies globally. The CMRPD, Clinical Safety Office (CSO) provides comprehensive clinical safety management and oversight support to the various clinical research initiatives of the NIAID, DCR.

KEY ROLES/RESPONSIBILITIES

• Provides broadly based regulatory, ethical, GCP and medical evaluation of key documents including protocols, informed consent documents, and investigator brochures for proposed and ongoing clinical trials, as well as related administrative activities to help ensure efficient, effective, and compliant study conduct and safety oversight of drug, vaccine, biologic, diagnostic, and device research that includes FDA investigational drug (IND) and device (IDE) safety data monitoring, review and reporting
• Provides Clinical Safety and Regulatory Compliance focused review of new research protocols and amendments
• Assists in the initial processing of Serious Adverse Events (SAEs), assessing each SAE report for clinical significance
• Works closely with study teams, government customer, and the RCHSPP regulatory and monitoring groups to facilitate timely, complete, accurate, and informative adverse event reporting to other regulatory and oversight entities such as FDA and IRBs
• Performs investigational product safety reviews and participates in the preparation of technical and regulatory documents
• Reviews and interprets clinical data on a real-time basis, including report review, teleconferences, and other activities in collaboration with the Principal Investigator or Data Management Center, if applicable, and makes recommendations and determinations as appropriate and required to help ensure the protection of study participants
• Reviews serious adverse event reports from clinical sites to determine if an Investigational New Drug (IND) Safety Report or an Unanticipated Adverse Device Effect Safety Report is needed
• In conjunction with responsible investigator, oversees and approves the preparation of safety information for reporting to regulatory bodies
• Ensures, in conjunction with Regulatory Affairs, compliance with regulatory reporting requirements for safety reporting in domestic and international clinical trials
• Assists with preparation of INDs and IND Annual Reports as they relate to clinical safety information
• Provides expert consultation, as appropriate, to Investigators and study teams on protocol procedures related to safety and compliance with regulations and guidance, including, but not limited to, population selection criteria and screening, safety testing, pausing and halting, blinding, DSMB and other safety oversight, communication of information and risks in plain language for informed consent, toxicity table selection, and rules governing protocol evaluation and reporting of serious adverse events, unanticipated problems, lab abnormalities, subject withdrawals, in accordance with regulatory requirements
• Serves on assigned project/product teams or sub teams to provide guidance regarding safety-related issues
• Provides representation and coverage for the Director of Clinical Safety and other Medical Monitor(s) as necessary to ensure smooth function and avoid gaps in oversight, and provides consultation, expertise and clinical leadership as appropriate for clinical and non-clinical members
• This position is located in Frederick, Maryland

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree from an accredited college/university in a field related to health or life sciences or four (4) years related experience in lieu of degree
• Foreign degrees must be evaluated for U.S. equivalency
• In addition to education requirement, a minimum of 2 years related experience
• Experience in technical writing with concentration in SAE reporting
• Ability to work in clinical research setting, both independently and within a team
• Knowledge of clinical trial fieldwork concepts and practices, Department of Health and Human Services and FDA regulations, National Institutes of Health policies, 21 CFR, and International Conference on Harmonization/Good Clinical Practices (ICH/GCPs)
• Knowledge of working databases
• Knowledge of medical and scientific procedures and patient safety issues for research protocols, and regulatory aspects of data safety monitoring
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Bachelor of Science in Nursing is preferred
• Clinical nursing experience with prior clinical trials and/or safety reporting experience
• Familiarity with regulatory requirements and guidelines for clinical research
• Ability to exercise good judgment in planning and accomplishing goals
• Must be able to work with various levels of scientific and administrative personnel

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

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