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Institutional Review Board Officer

at General Dynamics Information Technology

Posted: 10/8/2019
Job Reference #: 54629
Keywords: response

Job Description

  • Job LocationUSA-MD-Ft Detrick
    Requisition ID
    2019-54629
    # of Openings
    1
    Job Function
    Science and Engineering
    Security Clearance Level
    None
    Full/Part Time
    Full Time
  • Job Description

    GDIT is seeking a candidate to support the USAMRMC Office of Research Protections (ORP) Institutional Review Board Office (IRBO). The ORP Human Research Protections Office (HRPO) provides the unique DoD-required headquarters-level administrative human subjects protection regulatory reviews and determinations for USAMRMC-supported research. The ORP IRBO supports the activities of the HQ USAMRMC IRB to provide federally required IRB review, approval, and oversight for human research conducted by customers of the HQ USAMRMC IRB.

    Responsibilities:

    Comprehensive Research Protocol Pre-review

    Using government provided policies, procedures, checklists, and information systems, the IRBO employee shall facilitate investigator’s pursuit of HQ USAMRMC IRB approval through comprehensive pre-review of protocols submitted to the HQ USAMRMC IRB for expedited or convened IRB review. Working under direct supervision of the Director, IRBO or Deputy Director, IRBO, the employee shall provide a comprehensive, timely, professional quality, and fully documented pre-review of each assigned protocol for regulatory compliance before it is sent to the IRB Chair or convened IRB for action or consideration of approval. The employee shall provide regulatory- based written pre-review of new protocols following an IRBO required format using standardized checklists.

    Conduct pre-reviews of projects submitted to the HQ USAMRMC IRB Office for determination of the applicability of the human subjects protection regulations.

    Prepare correspondence, response to customer inquiries to explain and interpret human subjects protection regulations and guidelines to investigators and other customers

    Attend meetings with HQ USAMRMC IRB customer representatives to address issues affecting the progression of protocols and assist in identifying problems and resolutions to problems.

    Formulate and recommend potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects research.

    Engage in email and telephone communications with the Principal Investigator and key study personnel to address questions, concerns, and outstanding issues.

    Post Approval Protocol Monitoring

    Provide post-IRB-approval lifecycle management of assigned protocols including, but not limited to, pre-review of amendments/addenda, continuing review reports, reports of unanticipated problems and serious adverse events, reports of serious or continuing noncompliance, reports of research suspension/termination, protocol deviations, subject complaints, and final study reports and provide a professional quality written review, as required. The IRBO employee shall provide regulatory-based written pre-review of protocol life cycle actions following a IRBO-required format using standardized checklists.

    Provide support for the conduct of site visits to HQ USAMRMC IRB customer institutions to monitor compliance with HQ USAMRMC IRB-approved protocols and human subjects protection regulations, and assist in the conduct of noncompliance investigations and compliance inspections of HQ USAMRMC IRB protocols. Support includes preparing, planning, conducting, and reporting on compliance inspections of research for which the HQ USAMRMC IRB has oversight.

    The employee shall provide completed site visit/inspection checklists, written findings from site visit and compliance inspection activities. The employee shall assist in the preparation of the written report of each compliance inspection that includes written specific findings of the inspection. The employee shall travel to sites, as needed, to support IRBO federal personnel in compliance oversight of HQ USAMRMC IRB protocols.

    Human Subjects Protection Policies and Procedures Development

    Assist in development, update, and continuous improvement of the HQ USAMRMC IRB’s human subjects protection policies, procedures, guidelines, templates, and review checklists to ensure regulatory compliance with current laws, regulations, and policies governing human subjects research.

    Human Subjects Protection Education and Training

    Contribute to the development, coordination, and conduct of innovative human subjects protection regulatory compliance education and training programs targeted at HQ USAMRMC IRB members and the IRB’s customers. The employee shall prepare appropriate training packets and other materials for training. The IRBO employee shall interact with colleagues, HQ USAMRMC IRB members, and the IRB’s customers to gather or disseminate information or to provide assistance related to assigned protocols, attend meetings and conference calls as necessary, and provide education on human subjects protection regulations and IRBO/HQ USAMRMC IRB requirements.

    Acquire and retain knowledge of current Federal, DoD, DA, state, host nation, and USAMRMC regulatory requirements related to the protection of human subjects in research and cadaver use and apply knowledge of these regulations and general ethical principles during IRBO pre-reviews of assigned projects.

    Quality Assurance

    Actively manage and update protocol files and the information management systems used to track information related to protocol review, i.e., contractor personnel must master entry of protocol-related information into automated information management systems, and keep protocol status and event information complete and up to date. The employee shall assess the contractor work products for accuracy, timeliness, and adherence to ORP IRBO requirements regarding regulatory reviews, automated data information system entries and use of the shared computer drive. The employee shall assist in the execution of an internal quality control/assurance program.

    Performance Improvement

    Assist in the conduct of performance improvement activities to include participation in task-specific working groups aimed at improving and streamlining the HQ USAMRMC IRB’s protocol review and approval process.

    Education

    BS

    Qualifications

    5+ years of relevant IRB experience, providing comptehensive protocol review and approval. Expertise in human subjects protection regulations.

    For more than 50 years, General Dynamics Information Technology has served as a trusted provider of information technology, systems engineering, training and professional services to customers across federal, state, and local governments, and in the commercial sector. Over 40,000 GDIT professionals deliver enterprise solutions, manage mission-critical IT programs and provide mission support services worldwide. GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

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