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Documentation Specialist II (Regulatory)

Job ID: req1181
Employee Type: exempt full-time
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 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)/Regulatory Compliance and Human Subjects Protection Program (RCHSPP), provides specialized document support to the National Institute of Allergy and Infectious Diseases (NIAID) Intramural Clinical Research Community, Division of Clinical Research (DCR), Office of Clinical Research Policy and Regulatory Oversight (OCRPRO). 

KEY ROLES/RESPONSIBILITIES

  • Maintains accurate and secure filing systems for both electronic and hard copy documentation, to include current active/effective documents, inactive/obsolete documents, and archived documents/records
  • Formats RCHSPP/CMRPD controlled documents, processing each document through the appropriate review and approval cycles
  • Provides end user technical support for the Electronic Document Records Management System (EDRMS) and provide guidance regarding general document control issues
  • Works with Document Control management to create and revise direction sheets and policies/procedures applicable to the group
  • Facilitates review of clinical protocols within the EDRMS and TrackWise systems
  • Adheres to applicable regulatory requirements and policies regarding storage and retention of clinical research records, and ensure proper administrative controls are in place
  • Maintains master documentation and archives
  • Participates in the continuous improvement of the EDRMS, submitting helpdesk tickets and reporting system issues as needed
  • Participates in the facilitation of offsite document storage
  • May perform the following duties as required: prepare monthly metrics and/or status reports, perform internal audits, order supplies, schedule routine preventive maintenance of document control equipment, participate in cross-functional meetings/projects, train new employees on use of EDRMS
  • This position is located in Frederick, Maryland 

BASIC QUALIFICATIONS

  • Possession of a Bachelor’s degree in a related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education)
  • Foreign degrees must be evaluated for U.S. equivalency
  • A minimum of two (2) years relevant experience
  • Proficiency in Adobe Acrobat, Microsoft Word, Excel and Outlook
  • Knowledge of documentation systems and FDA regulations for CGMP, GLP, or GCP
  • Ability to work under pressure and meet deadlines
  • Ability to perform work on complex projects with minimal supervision
  • Ability to adapt and adjust to changing priorities and varying workloads
  • Strong organizational skills with a high attention to detail
  • Good command of grammar and punctuation rules
  • Ability to function effectively within a team environment
  • Excellent communication skills
  • Ability to handle and follow up on more than one task or project
  • Must be able to obtain and maintain a security clearance 

PREFERRED QUALIFICATIONS

  • Experience working with electronic document management system(s)
  • Experience with clinical research (GCP) and/or other regulated environments (GxP)
  • Familiarity with scientific or engineering terminology/principles
  • Familiarity with TrackWise and/or OpenText Content Suite systems

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

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