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    Duties

    Summary

    This position works in the Research and Development Service at the VA Western New York Healthcare System in Buffalo, NY.

    Learn more about this agency

    Responsibilities

    The Program Analyst - Research has primary administrative oversight and responsibility for the Human Research Protection Program to safeguard the rights and welfare of human research subjects.

    Duties includes, but may not be limited to the following:

    • Advises, informs and instructs research investigators and research team personnel on proper submissions of the protocol, optimum submission strategies, and assures compliance with Federal regulations, Institutional Review Board (IRB) and other applicable requirements.
    • Oversees the research compliance mail in-box, processes new transactions, follow-up on research issues, archives and tracks transactions and regulatory documents.
    • Educates investigators and coordinators on research and IRB submission applications.
    • Organizes and tracks multiple simultaneous research projects, multiple committees and reviewers. Provides administrative support to direct, interact, collect and process documents for up to 5 subcommittee reviews and up to 6 other individual pre-reviews on research projects.
    • Creates annual calendars, monthly agendas and prepares submission documents for each committee/sub-committee. Agendas include attention to detail on human research transactions (amendments, reviews, close-out, items of adverse events, non-compliance in the performance of research).
    • Reviews IRB and Research submissions and communicates deficiencies found to investigators.
    • Prepares letters describing the official conclusions of meeting deliberations. Communicates unapproved research, communicates directly with the MD/PhD research investigator, refer to them to Research Compliance (RC) Officer/RC Nurse, and follow up until issues are resolved. Serves as liaison between reviewers and investigators.
    • Maintains knowledge of policies, handbooks, and other requirements for research. This will involve participating in conference calls; interpreting policy, guidance and directives; attending meetings, contacting national-level content experts for clarification.
    • Serve as program manager for the up-keep of databases designed by research, supporting 300 or more research projects, which manages research projects, initial and annual progress reports, and annual renewal of human studies. Manages the research study databases, used to monitor/track research activity. Responsible for the integrity, accuracy, current data of the databases.
    • Manages principle investigators publication submission(s) program.
    • Coordinates and prepares for inspection team(s) visits and facilitates the teams' review of documents, investigators, and internal and external affiliated members.
    • Performs other duties as necessary


    Work Schedule: Monday-Friday, 8:00am - 4:30pm
    Recruitment & Relocation Incentives: Not authorized
    Financial Disclosure Report: Not Required

    Travel Required

    Not required

    Supervisory status

    No

    Promotion Potential

    9

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/539840000. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.