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 (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR) Office of the Clinical Director for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration.
Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials
Will focus on responsibilities and requirements for submission of clinical protocols and other required documents/components to the FDA for CCR-held investigational new drug (IND)/investigational device exemption (IDE) applications
Streamlines protocol development timeline
Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities
Provides technical review and report preparation
Provides administrative coordination and general logistical support for regulatory activities
Ensures the provision of training for investigators and associate staff to reinforce and enhance a GCP culture
Provides quality assurance and quality control oversight
Performs regulatory review of clinical protocols, informed consent and other clinical documents
Coordinates submission of protocols for the FDA
Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events
Assists clinical investigators in understanding and complying with the entire review process
Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document management and tracking system for NCI protocols
Converts protocols from word format to PDF with bookmarks
Formats protocols and manages requirements for electronic submission of documents to FDA per electronic common technical document (eCTD) criteria
Maintains the PDF version of the most current approved version of each active clinical protocol on a central server
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 education requirements, a minimum of six (6) years progressively responsible clinical trial protocol development and management experience
Ability to serve as a liaison with various NCI staff and Principal Investigators to initiate and complete tasks relating to oncology clinical protocols
Ability to interpret International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines
Ability to troubleshoot and appropriately report unexpected problems that may arise during the conduct of clinical trials
Advanced knowledge and skill of the tracking system functions for NCI protocols and provide reports to clinical investigators and the Branch Chiefs
Advanced knowledge of formatting word documents
Must be able to obtain and maintain a security clearance
About Leidos Biomedical Research, Inc. / Frederick National Lab for Cancer Research
The Frederick National Laboratory for Cancer Research is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab is working at the forefront of basic, translational, and clinical science with a focus on cancer, AIDS, and infectious disease. We operate in the public interest as a shared national resource, and collaborate with public and private partners to discover, to innovate, and to improve human health.