baltimoreprogrammer | Protocol Data Analyst I in Rockville, MD

Protocol Data Analyst I

  • Frederick National Laboratory for Cancer Research
  • $76,955.00 - 131,300.00 / Year *
  • 101 Leland St
  • Rockville, MD 20847
  • Full-Time
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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 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.
  • Reviews documents, validates trial information, and abstracts 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
  • Ensures trial summary report TSR accuracy and consistency while adhering to time expectations
  • Works closely with internal groups (CTEP, DCP, CCR etc.) and external sites on data verification
  • 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
  • Assists in improving standard operating procedures (SOPs) and CTRP User Guides
  • Performs data cleanup duties
  • Performs related duties as assigned
  • This position is located in Rockville, Maryland

BASIC QUALIFICATIONS
  • Possession of an 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
  • Exceptional written and oral communication skills with expertise with grammar, syntax, and formatting
  • 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 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
  • Additional experience with a Bachelor's degree is preferred
  • Experience in a pharmaceutical, biotechnology and/or clinical environment which includes medical and regulatory technical writing/editing
  • Familiarity with clinical trials, both interventional and non-interventional
  • 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)


* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.