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Somerville

    Human Research Compliance and Auditing Specialist - Somerville, United States - Mass General Brigham

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    Description

    Join Our Team - Human Research Compliance Specialist

    Are you ready to play a key role in ensuring that human subject research meets the highest standards? Look no further!

    The Company:

    Our Human Research Affairs Compliance and Education Office, part of Mass General Brigham, has been at the forefront of quality assurance and improvement in research since June 1999. We work closely with our research community to uphold federal, state, and local regulations, Good Clinical Practice, and institutional policies.

    Role Overview:

    The Human Research Compliance Specialist is an essential team member responsible for auditing clinical research protocols and providing education and support to researchers. Some key responsibilities include:

    • Performing audits of study files and providing noncompliance assessments.
    • Offering education and support to research teams.
    • Assisting in the development of study management tools and templates.
    • Educating investigators on regulatory requirements.
    • Representing the team in regulatory work groups.
    • Staying up-to-date on relevant laws and regulations.

    Qualifications:

    • Bachelor's degree required; Master's degree preferred.
    • 5-7 years' experience in human subject research.
    • In-depth knowledge of GCP guidelines and clinical research regulations.
    • Proficiency in Microsoft Office.
    • EEO Statement.

    The Good Stuff:

    Our core values guide our work and interactions, ensuring we provide the best support and maintain a diverse, inclusive environment. If you're passionate about human subject research and compliance, join us! Apply now!



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