The Frederick National Lab for Cancer Research (FNLCR) is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.
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.
The Clinical Monitoring Research Program (CMRP) provides project operations and subcontract management support for the National Cancer Institute’s (NCI’s) Center for Cancer Research Neuro-Oncology Branch. This position provides support to the Brain Tumor Trials Collaborative (BTTC). The BTTC is a network of clinical sites with the expertise to participate in state of the art clinical trials investigating new treatments for malignant brain tumors (https://ccr.cancer.gov/neuro-oncology-branch/bttc).
Monitors and oversees activities pertaining to clinical protocols such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing trials
Assists with writing protocols and protocol amendments to ensure regulatory requirements
Oversees ongoing protocol operations to ensure study compliance and troubleshoots possible protocol violations
Coordinates various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
Interfaces with the Protocol Support Office
Participates in clinical trial protocol development
Develops procedure manuals for clinical trial protocols
Assists in the creation of case report forms
Advises on and participates in the management and evaluation of multiple clinical protocols
Interacts with auditing and monitoring agencies to facilitate the exchange of data Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved
Ensures quality and human subjects protection
Assists the Principal Investigator in interpreting research data for dissemination to the protocol team
May conduct updates for clinical staff on patient care, protocol process and progress, human subjects protection, International Conference on Harmonization/Good Clinical Practices, and quality assurance education
May visit off-site collaborative centers
Will primarily provide high level administrative and coordination support to the BTTC with very limited interaction with study participants
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
Must possess a degree or diploma from a professional nursing program approved by a legally designated State accrediting agency at the time the program was completed
Current State license as a registered nurse (RN)
Foreign degrees must be evaluated for U.S. equivalency
In addition to the educational requirements, a minimum of one (1) year nursing and/or related clinical research experience
Knowledge of clinical research data collection and clinical data report preparation
Experience in the coordination, implementation, and execution of clinical trials
Ability to work in a data management setting in the capture and analysis of patient data including toxicity assessment, drug administration, laboratory results, and tumor response
Ability to communicate effectively
Must be able to obtain and maintain a security clearance
Candidates with these desired skills will be given preferential consideration:
Experience in a clinical trials outpatient setting
Please apply at https://jobs.leidos.com/ShowJob/Id/1744227/Multi-Site-Study-Coordinator-(NCI)/
For more information, please contact Lauri Rimorin at 301-846-7324 or email@example.com.
With over 2,000 employees, we believe people are our greatest resource and offer an outstanding salary and benefits program, including medical, dental, disability coverage, life insurance, retirement savings plans, educational assistance and health club membership reimbursement, just to name a few.
Leidos is an Equal Opportunity Employer M/F/D/V
Internal Number: 659620
About Leidos Biomedical Research, Inc.
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 NC...I 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. For more information about the Clinical Monitoring Research Program please visit http://cmrp.ncifcrf.gov/CMRP/Default.aspx