Job Information
Michigan Technological University Manager, Human Research Protection Program in Houghton, Michigan
Department: Associate Vice President for Research Development
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
If you require any auxiliary aids, services, or other accommodations to apply for employment, or for an interview, at Michigan Technological University, please notify the Human Resources office at 906-487-2280 or .
Job Description Summary
The Manager 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 Manager, 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.
Essential Duties & Responsibilities (other duties may be assigned)
- 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.
Required Education, Certifications, Licensures (minimum requirements)
Bachelor's degree.
Required Experience (minimum requirements)
Experience working with multiple stakeholders and managing relationships across various stakeholders
Desirable Education and/or Experience
- Experience with human research compliance, regulatory complianc