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Clinical Protocol Data Analyst I

Job ID: req1806
Employee Type: exempt full-time
Facility: Rockville: 9609 MedCtrDr
Location: 9609 Medical Center Dr, Rockville, MD 20850 USA

The Frederick National Laboratory 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 addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

PROGRAM DESCRIPTION

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
  • 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
  • Manages and performs data cleanup duties
  • Contributes to process and application improvements including participation in revision of standard operating procedures SOPs and CTRP User Guides
  • This position is located in Rockville, Maryland

BASIC QUALIFICATIONS

  • Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency
  • No work experience required with a Bachelor's degree
  • 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 personnel
  • Ability to work within a team and independently
  • Must be detail oriented
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Bachelor’s degree preferably in a clinical, biological/biomedical science or healthcare related field
  • Minimum of one (1) year 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
  • 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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