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 clinical research and case study coordination support to the clinics operated by the National Institute of Allergy and Infectious Diseases (NIAIDs) Division of Clinical Research (DCR), Intramural Clinical Management and Operations Branch (ICMOB)
The Protocol Nurse Coordinator (PNC) II: 1) documents patient care via established guidelines, 2) assesses, plans and follows up with disease-noted attributes, 3) coordinates patient schedules, data collection and nursing care, 4) consults with other health care professionals to meet the medical, social and/or psychological needs of patients, 5) assists physicians with skilled procedures, 6) orders protocol mandated tests, labs and procedures, 7) alerts physician of Adverse Events, abnormal outcomes and/or problematic trends, 8) enters protocol data in database management system, 9) follows patients between visits and collaborates with community physicians, 10) serves as a liaison between personnel at clinical and laboratory sites, the Principal Investigator (PI), as well as sponsoring pharmaceutical companies, 11) participates in clinical trials protocol development, develops procedure manuals for clinical trials protocols and assists in the creation of Case Report Forms, 12) oversees ongoing protocol operations to ensure study compliance and troubleshoots possible protocol violations, 13) interfaces with NIAID’s Institutional Review Board and coordinates to ensure proper and timely filing of Serious Adverse Events, amendments, annual reports and other regulatory documents, 14) conducts updates for clinical staff on patient care, protocol process and progress, human subjects protection, International Conference on Harmonization/Good Clinical Practices (ICH/GCP) and Quality Assurance (QA) education, and 15) assists the PI in interpreting research data for the protocol team
Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field or four (4) years related experience in lieu of degree.
Foreign degrees must be evaluated for U.S. equivalency
Possession of a current professional license as a Registered Nurse (RN) from any U.S. state
A minimum of five (5) years progressively responsible nursing experience
Knowledge of clinical research data collection and clinical data report preparation
Working knowledge of ICH/GCPs
Experience working in a data management setting in the capture and analysis of patient data, including toxicity assessment, drug administration and laboratory results as they relate to diagnosis and treatment plans
Professional knowledge of the principles, theories, techniques and practices of nursing with immunologic illnesses
Possesses a working knowledge of the related disciplines of epidemiology, microbiology, immunology, serology, pharmacology, clinical medicine and biostatistics
Ability to work independently and to troubleshoot unexpected problems that may arise during the conduct of clinical trials
Must be CPR certified or certifiable
Prior experience in adult and pediatric clinical trials management
Ability to operate word processing and spreadsheet applications independently with accuracy and speed
General knowledge of biological principles and scientific methods