Clinical Program Administrative Supervisor
Job ID: req629
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA
The Frederick National Laboratory is dedicated to improving human health through discovery and innovation in the biomedical sciences, focusing on cancer, AIDS, and emerging infectious diseases.
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 program administrative support to the clinics operated by the Office of the Clinical Director (OCD), Center for Cancer Research (CCR), National Cancer Institute (NCI) at the National Institutes of Health (NIH).
- Assists with the administration of the complex clinical program and ensures major components and initiatives in the areas of patient care, clinical research staff recruitment, training and resource management are well integrated and move forward efficiently and effectively
- Interacts with various internal and external groups to facilitate clinical trials research and develop administrative procedures
- Acts as liaison between outpatient clinics, the Clinical Center and other departments
- Identifies solutions for day-to-day problems by adapting processes and procedures with consideration to the coordination of patient care
- Assists in monitoring, control and reporting on clinical budgets
- Develops project timelines and tracks the progress of clinical projects
- Prepares reports and reviews sections of submissions, abstracts and presentations
- Completes special projects
- Tracks progress, and monitors/prepares budget operating reports
- Works in conjunction and collaboration with NCI academic clinical scientists, research investigators and/or groups that participate in clinical research trials or influence clinical research
- Responsible for implementing operating guidelines utilizing standard NCI Policies and Standard Operating Procedures (SOPs)
- Reviews operational requirements for development of or changes to staffing
- Performs assignments and tasks independently; however unusual or difficult problems are referred for review to the Administrative Director
- Supervises other administrative clinical support staff
- This position is located in Bethesda, Maryland
- Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the educational requirements, a minimum of six (6) years of responsible administrative experience in a hospital or medical environment, including two (2) years in a supervisory capacity
- Experience should include work with protocols, clinical site management, data collection and analysis
- Must possess general knowledge of clinical trial fieldwork concepts and practices, regulatory requirements and guidelines for clinical research and monitoring requirements
- Must be well versed in Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
- Must be able to perform project management-type tasks for multiple clinical research protocols
- Must be able to obtain and maintain a security clearance
- Familiarity with State Department Regulations and FARs
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)