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 clinical trials management, regulatory, and protocol navigation support to Phase I and II clinical trials being conducted by the National Institute of Health's (NIH's) National Institute of Neurological Disorders and Stroke (NINDS). KEY ROLES/RESPONSIBILITIES Provides clinical trials regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned Works with Principal Investigators (PIs) on protocol writing and editing (including format and addition of administrative sections); prepare amendments, continuing reviews, reportable events reports, including all necessary forms Works with research staff on the development of clinical research and clinical trial protocols, informed consent documents, and other regulatory or study-related documents Reviews and ensures protocols and informed consents meet regulatory requirements and are written in a compatible format with the guidelines Works with research teams and NINDS Clinical Trials Unit (CTU) staff to prepare submissions to the appropriate regulatory bodies (eg Institutional Review Board, Data and Safety Monitoring Entity, Radiation Safety Committee, etc.,) Protects and ensures the safety of patients on research protocols through reporting of toxicities, trends in protocol results, and other concerns to the PI and Medically Responsible Investigator (if not the PI) Collaborates with staff on IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports Manages, tracks and coordinates regulatory activities for all assigned protocols, under the guidance of the PIs, from conception/development, through the protocol lifecycle, to study closures Manages and tracks training requirements of study investigators on IRB approved protocols. In addition, reviews all offsite investigator activities making sure proper special agreements are in place Maintains all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports Works with PI and associated research staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies as needed Works with the NINDS CTU and NINDS staff on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing for the NINDS Intramural Research Program Prepares draft documents for senior staff review Attends in-person meeting located at the NIH campus in Bethesda including weekly CTU staff meetings, protocol development meetings, research coordinator forum meetings, as well as regular research team meetings Initiates and oversees revisions to documents as indicated in corrective and preventive action plans Collaborates with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, CTU-staff, and safety, regulatory, and monitoring entities Coordinates with other offices (eg, Office of Human Subjects Research Protections, Office of Regulatory Support and Compliance, NINDS and NIH offices involved in communication) to integrate and ensure consistency of new/revised documents with policies Attends training activities to maintain a current clinical trial and Good Clinical Practice (GCP) knowledge base, in order to serve as an expert resource to the client in a regularly changing field This position is located in Bethesda, Maryland BASIC QUALIFICATIONS 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 US equivalency In addition to the educational requirements, a minimum of five (5) years of progressively responsible experience in biomedical research, including a minimum of four (4) year directly related to overseeing multiple concurrent projects that comprise diverse functions of clinical research implementation processes and conduct Experience in a clinical research setting with protocols and clinical trials, such as protocol navigation/clinical research regulatory support or other related field (such as quality assurance monitoring; human research subject protection work) 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, FDA regulations (specifically IND regulations), Good Clinical Practices (GCPs), international guidelines, and other guidelines for clinical research, including the requirements of the institutional review board (IRB) 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 Experience with electronic data-management including proficiency in navigating clinical trials databases as well as other platforms including MS Excel, etc. Experience interacting with the FDA, IRBs, and other regulatory bodies in order to make all required regulatory submission and address questions/stipulations Experience with Contract Research Organizations (CROs) and pharmaceutical companies Ability to submit quality products under tight deadlines 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 Familiarity with neurological disorders and stroke 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 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