Protocol Data Analyst II

Frederick National Laboratory for Cancer Research
Rockville, MD
Jan 14, 2019
Jan 16, 2019
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. KEY ROLES/RESPONSIBILITIES 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 Completes trials registrations and trial updates Responds to inquiries and resolves issues addressed by the cancer research community or stakeholders utilizing effective communication Organizes and monitors issues using an issue/ticket tracking system Performs tasks related to individuals and organizations curation for the Clinical Trials Reporting Program (CTRP) Maintains the database of existing individuals and organizations Works closely with internal groups (CTEP, DCP, CCR etc.) and external sites on data verification Identifies and addresses data discrepancies in the PA application to ensure data standardization/harmonization across clinical trials within CTRP Ensures trial summary report TSR accuracy and consistency while adhering to time expectations Effectively communicates with trial submitters to address requests, questions, concerns and clearly document actions taken Manages and performs data cleanup duties Performs quality control reviews of clinical trial reports and provides constructive feedback to colleagues Contributes to process and application improvements including participation in revision of standard operating procedures SOPs and CTRP User Guides Handles special requests or other duties in support of CTRP Trains junior employees and participates in cancer center trainings Develops training material for cancer centers, and updates 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), preferably in a clinical, biological/biomedical science or healthcare related field (Additional qualifying experience may be substituted for the required education) Foreign degrees must be evaluated for US equivalency In addition to the educational requirements, a minimum of two (2) year of experience in a pharmaceutical, biotechnology and/or clinical environment which includes medical and regulatory technical writing/editing Exceptional written and oral communication skills with expertise with grammar, syntax, and formatting Ability to work in a fast-paced environment, both independently and within a team 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 Ability to mentor junior staff Must be detail oriented Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Familiarity with areas of clinical trials, both interventional and non-interventional Ability to work in a busy setting, both independently and within a team Ability to troubleshoot and appropriately report unexpected problems that may arise during the curation of Persons and Organizations Ability to effectively incorporate diverse feedback from the user community into a high-quality document Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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