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Director, Regulatory Oversight and Compliance

2 months ago

Washington, United States George Washington University Full time
Job Summary

The George Washington University seeks a highly skilled and experienced Director, Regulatory Oversight to lead the administrative, regulatory, and programmatic activities supporting the university's Human Research Protection Program (HRPP), animal care and use program, and oversight committees for the use of recombinant DNA and biohazardous materials, and research involving human embryonic and/or pluripotent stem cells.

Key Responsibilities
  • Strategic Leadership: Provide strategic leadership and operational direction to the Office of Human Research (OHR) and Office of Research Safety (ORS) teams.
  • Regulatory Oversight: Oversee the administrative, regulatory, and programmatic activities of the Institutional Review Boards (IRB), Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), Stem Cell Research Oversight Committee (SCRO), and Laser safety program.
  • Accreditation and Compliance: Ensure a thorough review of research protocols prior to submission to the regulatory committees for review; facilitate maintenance of AAALAC accreditation; support and oversee AAHRPP accreditation.
  • Emergency Response: Direct biological and radiation safety during emergencies and planned special events at the university.
  • Staff Management: Oversee management of and ensure development for staff to meet overall objectives; provide leadership and communication to maintain a competent and engaged employee group.
  • Regulatory Guidance: Provide expert regulatory guidance to researchers, staff, committee members, and leadership.
  • Education and Outreach: Develop, deliver, and maintain education and outreach programming in collaboration with the Executive Director for Research Integrity and Compliance.
  • Administrative Management: Oversee administrative management of protocols; develop and maintain and enforce safety standards, policies, and standard operating procedures.
Requirements
  • Education: Bachelor's degree in a related field.
  • Experience: Minimum 5 years of experience in regulatory affairs, research compliance, or a related field.
  • Skills: Strong leadership and communication skills; ability to work in a fast-paced environment; knowledge of regulatory requirements and compliance standards.