Leidos Biomedical Research, Inc. (LBRI), a wholly owned subsidiary of Leidos, operates the Frederick National Laboratory for Cancer Research (FNLCR). FNLCR is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI). It is the only FFRDC dedicated to biomedical research. Through its status as an FFRDC, FNLCR provides NCI and others with a unique national resource to accelerate the development and delivery of effective preventive, diagnostic, and therapeutic products for cancer and AIDS.
The breadth of FNLCR’s activities spans the research and development spectrum, including investigator-initiated, hypothesis-driven research into cancer and AIDS; advanced technology programs focused on genetics and genomics, proteins and proteomics, imaging, nanotechnology, bioinformatics, and laboratory animal sciences; clinical operations in support of NCI and National Institute of Allergy and Infectious Diseases (NIAID)-sponsored clinical trials, as well as NCI drug discovery and development efforts; and management and operations of biopharmaceutical development and manufacturing programs under current Good Manufacturing Practice conditions for NCI and NIAID. Administrative, procurement, financial, safety, and facilities support is provided to these R&D activities through state-of-the-art business processes. LBRI has approximately 1,900 employees and manages an annual operating budget of approximately $450M.
For more information about Leidos Biomedical Research Inc., please visit our webpage at www.leidosbiomed.com.
Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) 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 Institute of 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, CMRP’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. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health 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, CMRP services include comprehensive clinical trials, 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. CMRP’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 (CMRP) provides comprehensive, dedicated project management and clinical research to the National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC) for development of therapeutic and vaccines products, diagnostics, assays, and immune correlates leading to protection against flaviviruses, including Zika, advancing countermeasures protecting against flavivirus infection.
The Clinical Trials Manager I (CTM I): 1) serves as one of the CMRP project leads, 2) assists with the planning and implementation of clinical trials, 3) participates in managing and coordinating project activities for the Zika Phase IIB clinical study (and others), 4) acts as a liaison between various Leidos Biomed, NIAID entities and collaborating offices, interacting with both scientific and administrative officials, 5) coordinates and communicates efforts within the assigned activities to include organizing, planning, executing, reporting and evaluating the assigned program objectives, 6) collaborates with Clinical Research Organizations (CROs) on site management activities, 7) identifies and assesses clinical trial sites and the necessary infrastructure to carry out clinical studies domestically and internationally, including: clinical site assessment, clinical site preparation, clinical site training and clinical site logistical support, 8) coordinates meetings between various CROs and clinical sites, 9) provides mentoring, leadership and supervision to the Clinical Data Associate II (CDA II), 10) reviews sponsor protocol edits and Informed Consent Forms (ICF) edits, case report forms, study templates and manual of operations, 11) reviews site audit reports from CDA II prior to and upon completion, 12) assists with CMRP site audits as needed, and 13) travels up to 20%.
This position is located in Frederick, Maryland
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/clinical trials/health or four (4) years related experience in lieu of degree
Foreign degrees must be evaluated for U.S. equivalency
A minimum of six (6) years related experience in a pharmaceutical, biotechnology and/or clinical environment
Clinical trial project management experience
Experience in preparing site management budgets
Proficiency in all functions of clinical research implementation processes and conduct
In-depth knowledge of the clinical trial and drug development process
Experience in data management and subcontracting
Ability to work in a clinical research setting both independently and within a team to coordinate, negotiate, and facilitate data
Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCP)
Knowledge of clinical trial fieldwork concepts and practices
Strong customer focus with the ability to communicate effectively, both verbally and in writing
Strong problem solving, planning and organizational skills
Ability to prioritize multiple tasks and projects
Cancer and infectious disease research experience
Knowledge of Quality Assurance/Quality Control processes
Knowledge of site selection activities and tracking site capabilities
Progressively increasing clinical site monitoring/auditing experience, management of multiple concurrent clinical trials/projects and supervisory experience