User Support Specialist

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.

KEY ROLES/RESPONSIBILITIES

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.

• Triage electronic requests from cancer centers to appropriate personnel and respond to requests within 24-48 hours of receipt
• Responds to inquiries and resolves issues addressed by the cancer research community or stakeholders utilizing effective communication
• Organize and monitor issues using an issue/ticket tracking system
• Investigate accrual (patient enrollment) and data report inquiries from NCI-designated cancer centers. Review and analyze CTRP and external source systems to reconcile data, and coordinate with the stakeholders to investigate and rectify data discrepancies.
• Initiate and provide CTRP user training reviews of data reports, trial registration for site administrators and members
• Manage and perform data update projects, follow up with centers to answer questions on trial registration, funding categorization, participating site statuses and accrual discrepancies
• Imports NCI Center for Cancer Research (CCR) trials from ClinicalTrials.gov and registers them in CTRP, completes trials registrations for new trials and amendments as requested for NCI - managed and/or sponsored trials
• Reviews documents, validates trial information, and abstract relevant administrative data following standard guidelines
• Performs necessary outreach to the cancer center community to obtain missing trial submission information
• Performs quality control checks to provide accurate, timely, and consistent clinical data abstractions
• Perform tasks related to individuals and organizations curation for the Clinical Trials Reporting Program (CTRP)
• Maintain the database of existing individuals and organizations
• Work closely with internal groups and external sites on data verification
• Identify and address data discrepancies in the PA application to ensure data standardization/harmonization across clinical trials within CTRP
• Ensure trial summary report TSR accuracy and consistency while adhering to time expectations
• Effectively communicate with trial submitters to address requests, questions, concerns and clearly document actions taken
• Contribute to process and application improvements including participation in revision of standard operating procedures SOPs and CTRP User Guides
• Handle special requests or other duties in support of CTRP, as assigned
• Train junior employees and participate in cancer center trainings
• Develop training material for cancer centers, and update the materials when necessary
• This position is located in Rockville, Maryland

BASIC QUALIFICATIONS

• 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 beyond the Bachelor's degree
• Ability to analyze multiple systems and information sources and provide accurate results.
• Ability to prioritize multiple projects and deadlines in a short period of time and communicate status of projects effectively.
• Ability to troubleshoot and appropriately report unexpected problems that may arise during the data abstraction of clinical trials
• Proficient with computer usage and Microsoft Office applications
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Minimum of two (2) years of experience in a pharmaceutical, biotechnology and/or clinical environment which includes medical and regulatory technical writing/editing
• Familiarity with areas of clinical trials, both interventional and non-interventional
• Familiarity with data reporting requirements and Cancer Center Support Grant reporting requirements
• Ability to work in a fast paced setting, both independently and within a team
• Ability to effectively incorporate diverse feedback from the user community into a high-quality document
• Ability to effectively provide CTRP overviews to CTRP Users and communicate follow up items to team
• Exceptional written and oral communication skills with expertise with grammar, syntax, and formatting
• Ability to mentor Junior personnel
• Must be detail oriented

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