The Director of the Human Research Protection Program (HRPP) at Michigan Technological University (MTU) is charged with ensuring that the human research protections program complies with applicable laws, regulations, and policies. The Director, within the Office of Research Integrity, is responsible for oversight of the human research protections program including administration of the Institutional Review Board (IRB) as well as implementation and management of policies and procedures related to research involving human subjects.
NOTE: This position has the possibility of being remote with required travel to campus several times throughout the year
Essential Duties and Responsibilities:
Review protocols submitted for approval by IRB for completeness and compliance with the Office of Human Research Protections (OHRP) regulations, other Federal regulations, state and local laws, and IRB Policy and Procedures.
Provide oversight and support for the MTU IRB including evaluation of submissions for appropriate assignment of review category under Federal guidelines (e.g., Exempt, Expedited, Full Review).
May include IRB membership with responsibilities for Exempt determinations and Expedited reviews, as commensurate with the level of knowledge and expertise.
Maintain IRB Policy and Procedures Manual and recommend revisions/updates, as needed.
Provide education/outreach/training for the research community, as needed, regarding the overall HRPP, including, but not limited to: (a) determining when IRB review is necessary; (b) identifying appropriate categories of review; (c) protocol submission process and procedures including use of, and technical support for, the electronic submission system; and (d) the institutional HRPP education/training program (CITI).
Build relationships with internal stakeholders (including consulting with researchers) and liaise with the Office of Research Integrity and internal audit representatives as appropriate; work with various stakeholders to build a culture of compliance.
Assist researchers with compliance reporting requirements in accordance with Federal regulations.
Oversee the quality assurance monitoring of the HRPP, including investigation of matters of noncompliance; and ensure implementation of corrective action, as needed, in accordance with the policies and procedures of MTU and the IRB.
Represent MTU HRPP as a liaison with regulatory agencies, accrediting bodies (as applicable), and funding agencies.
Ensure HIPAA compliance.
Other related duties as assigned.
Required Experience (minimum requirements):
Experience working with multiple stakeholders and managing relationships across various stakeholders
Desirable Education / Experience:
Experience with human research compliance, regulatory compliance, IRB administration, or related fields.
Demonstrated understanding, and detailed working knowledge of federal regulations and agency guidelines for conducting research and the protection of human subjects.
Certified IRB Professional (CIP).
Master’s degree in a related field that included working with human subjects.
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