Clinical Information Specialist

Rockville, MD
Jul 13, 2019
Required Education
Bachelors Degree
Position Type
Full time
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 comprehensive database of information on all NCI-supported interventional clinical trials open to accrual as of January 1, 2009. This database, also referred to as CTRP, helps identify gaps and duplicate studies in clinical research, facilitates clinical trial prioritization, and standardizes trial data capture and sharing.

  • Review clinical trial documents for the NCI CTRP and apply standards to create trial summary reports
  • Index relevant disease, intervention, and biomarker terminology to support clinical trial searching
  • Ensure abstraction accuracy and consistency while adhering to time expectations
  • Update clinical trial records based on submitted protocol changes
  • Professionally address both internal and external feedback
  • Perform quality control reviews of summary reports and provide constructive feedback to colleagues
  • Contribute to process improvement initiatives, including revision of standard operating procedures
  • Effectively communicate with trial submitters to address requests/questions/concerns and clearly document actions taken
  • Execute data update and outreach projects in a timely manner
  • Efficiently troubleshoot or report any unexpected technical problems
  • Collaborate with application developers and perform user acceptance testing
  • Manage special requests or other duties in support of CTRP
  • 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 related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
  • No experience required with a Bachelor's degree
  • Must be able to obtain and maintain a security clearance

  • Experience in clinical trial reporting, medical writing and/or clinical research
  • Knowledge of clinical trial designs and protocols
  • Experience translating clinical information for a lay audience
  • Knowledge of cancer terminology, disease staging, and biomarkers
  • Experience with issue tracking systems and process documentation

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)