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    Regulatory & Compliance Specialist I - Worcester, United States - University of Massachusetts Medical School

    University of Massachusetts Medical School
    University of Massachusetts Medical School Worcester, United States

    3 days ago

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    Description

    Overview:

    POSITION SUMMARY:

    Under the direction of the Director or designee, the Regulatory and Compliance Specialist I is responsible for ensuring research regulatory affairs and compliance with federal and state regulations and institutional policies and procedures.

    Responsibilities:

    ESSENTIAL DUTIES:

    • Gather data, review, and triage the submissions of various initial and continuing review requests ensuring accuracy and the appropriate level of review according to the state and federal regulations
    • Assess submissions for consistency with regulation & compliance requirements
    • Track the metrics of the performance of processes (initial, continuing review, new information reporting, etc) as well as responses from investigators and research staff for resolution
    • Ensure that delegated pre-review process communications for investigators are handled efficiently
    • Prepare, review, and submit regulatory and compliance documents
    • Coordinate training to the research community
    • Coordinate central committee communication for meetings, agendas, approvals, etc.
    • Provide support for all web changes and enhancements of information
    • Compile data and assist in designing reports for internal and external audiences
    • Prepare, maintain and revise procedures or instruction manuals, and integrate changes
    • Perform other duties as required.
    Qualifications:

    REQUIRED QUALIFICATIONS:

    • Bachelors degree in science, a related field, or equivalent experience
    • 1-3 years of experience in research or regulatory/compliance administration or other relevant experience
    • Experience in handling confidential and sensitive material
    • Effective oral and written communication skills
    • Ability to prioritize, problem-solve and work under pressure in a deadline-driven environment

    Preferred Qualifications:

    • Experience in Institutional Animal Care and Use Committee (IACUC) administration.
    • Knowledge of regulations/guidelines pertaining to IACUC and animal care/use.
    Additional Information:

    Preferred Qualifications and Experience for IACUC Regulatory Specialist I:

    • Experience in Institutional Animal Care and Use Committee (IACUC) administration.
    • Knowledge of regulations/guidelines pertaining to IACUC and animal care/use.
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