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)/Clinical Trials Reporting Office (CTRO) supports the NCI's Clinical Trials Reporting Program (CTRP), which maintains a database of information on NCI-supported clinical trials. The CTRO team creates and maintains clinical trial summary records in the CTRP database. These records serve the NCI for portfolio analysis purposes and they are the source for information used to support the cancer research grants review process. Some of the clinical trial information that the CTRO abstracts is fed to public clinical trial search websites including Cancer.gov and ClinicalTrials.gov.
Leads a team of clinical data abstractors responsible for creating and maintaining summary reports of clinical trials funded by the NCI
Reviews the team’s summary reports and ensures that they accurately and consistently represent clinical trial protocols and related documentation
Ensures the team meets the contract expectations for trial summary report turnaround time (under 10 business days)
Coordinates orientation, training, and team-building activities for staff
Celebrates team achievements and report activities
Conducts periodic performance reviews; help team members to set and achieve goals
Ensures timely and accurate responses to inquiries submitted to the CTRO
Reviews feedback from diverse sources and address areas requiring data update or process improvement
Manages team data update and outreach projects; ensures timelines are accurately set and maintain communication with stakeholders
Fully investigates issues to be escalated to leadership and provide recommended actions
Participates in high-level meetings to support customer goals, clarifies expectations, and addresses concerns
Collaborates with stakeholders to facilitate the structuring of trial eligibility criteria to support matching of participants to clinical trials
Participates in stakeholder meetings; proposes and speaks to meeting agenda topics
Efficiently troubleshoots and reports unexpected technical problems
Collaborates with developers to propose system enhancements and performs user acceptance testing of new features
Handles special requests or other duties in support of CTRP, as assigned
This position is located in Rockville, 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 (Additional qualifying experience may be substituted for the required education) Foreign degrees must be evaluated for U.S. equivalency
In addition to educational requirements, a minimum of six (6) years of progressively responsible relevant experience in clinical research, including a minimum of 3 years supervising/leading teams or projects
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.