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. KEY ROLES/RESPONSIBILITIES The Clinical Monitoring Research Program Directorate (CMRPD) provides laboratory and protocol management support for the Molecular Imaging Branch (MIB), for the National Institute of Mental Health (NIMH). Performs or assists with all protocol document related activities, including submission of initial protocol and consents, submission of protocol amendments, reportable events and adverse events, continuing reviews, etc. to the IRB of record Maintains a schedule of all submission deadline dates and meeting dates for all active studies and INDs in the MIB portfolio Assists clinical investigators in understanding and complying with the entire review process, from preparation of documents required for submission to responding to pre-review and/or IRB stipulations Continuing Review: Gathers publications lists and accrual information Gathers reportable events and other occurrences Checks training for all Associate Investigators (AIs) Tracks data sharing agreements Problem Reports : Understands the FDA regulatory requirements for reportable events, adverse events and protocol deviations Gathers information when problems occur Advises staff on how to proceed Drafts report and follows up on reportable events to IRB and OCD and other designees as needed Supports the Principal Investigator (PI) in the development and oversight of regulatory documents Assists with the preparation of initial FDA IND and IDE submissions, annual reports and other reports as needed Maintains a file of all submission documents in a consistent and clear fashion to foster organization and access for team members Understands the requirements related to good clinical practice (GCP) and supports the team in the development and maintenance of regulatory documents and research files including: Protocol files, FDA files, regulatory binder, investigators' certificates and training, delegation of authority logs etc. as required by regulation. Works to create electronic files and databases that can be used by the team for data entry and analysis Performs periodic quality reviews to verify regulatory requirements are being met Supports the team in preparation for and during monitoring visits Assists with adverse event classification and reporting Works collaboratively with research team to accomplish goals of the branch in an efficient and constructive manner Supports team development activities and tracking of meetings and reports as needed Assists the PI and study team with orientation of trainees, maintain files of required trainings as needed Works with staff to identify problems with subject database and implement changes and improvements Collaborates with investigators to resolve any protocol/data issues Provides support to staff for abstract submissions, conference registrations, registration for educational courses, ordering of equipment Provides support to senior staff for annual reports, resource planning, lab reviews, presentations, literature reviews, etc. This position is located in Bethesda, 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 health/scientific, or medical related field (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 eight (8) years of progressively responsible regulatory experience Ability to serve as a liaison with various NIMH staff and Principal Investigators to initiate and complete tasks relating to neuroscience/psychology clinical protocols Ability to interpret International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines Ability to troubleshoot and appropriately report unexpected problems (UPs) that may arise during the conduct of clinical trials Advance knowledge and skill of the tracking system functions for NIMH protocols and provide reports to clinical investigators and the Branch Chiefs Advance knowledge of formatting word documents Ability to work independently and with a team Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Possession of a Master's degree in a neuroscience/psychology or related field Knowledge of clinical data report preparation Excellent inter-personal skills to effectively work with and train large groups Proficiency with Microsoft® software applications Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)