Manager, Human Research Protection Program

• IRB Administration
• 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.
• Includes IRB membership with responsibilities for Exempt determinations and Expedited reviews, as commensurate with the level of knowledge and expertise.
• 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).
• Creating letters of determination to researchers
• Maintain IRB Policy and Procedures Manual and recommend revisions/updates, as needed.
• Coordinate IRB training and membership development.
• HRPP Administration
• 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.
• Ensure HIPAA compliance.
• Other related duties as assigned.

• Bachelor's degree.

• Experience working with multiple stakeholders and managing relationships across various stakeholders

• 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.
• Master’s degree in a related field that included working with human subjects.

• Demonstrated effective verbal and written communication skills, including ability to constructively resolve conflicts and problem solve.
• Ability to synthesize information from multiple sources to produce succinct, detail-oriented, and accurate documents, policies, reports, and announcements.
• Ability to exercise sound and consistent judgment within a defined process.
• Strong interpersonal skills and ability to diplomatically navigate complex and sensitive situations.
• Advanced competence utilizing MS Office suite, computerized databases, and other technological products that facilitate effective management.
• Fluency in cloud- or remote-based computer environments and video conferences.
• Excellent interpersonal and customer service skills, along with the ability to effectively collaborate with a diverse constituent population, including remotely.

• Demonstrated ability to communicate effectively across cultural boundaries and work harmoniously with diverse groups of students, faculty, and staff.

Required University Training:

• Employee Safety Overview
• Anti-Harassment, Discrimination, Retaliation Training
• Annual Data Security Training
• Annual Title IX Training

Offers of employment are contingent upon and not considered finalized until the required background check has been performed and the results received and assessed.

Other Conditions of Employment:

The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment. Visa sponsorship is unavailable at this time. This is not an E-Verified Position.

Michigan Technological University is an Equal Opportunity Educational Institution/Equal Opportunity Employer that provides equal opportunity for all, including protected veterans and individuals with disabilities