IRB Reliance Manager

We are seeking a highly skilled and experienced individual to fill the role of Reliance Manager for the Human Research Protection Program (HRPP). The Reliance Manager will be responsible for oversight, implementation and management of policies and procedures governing IRB reliance. The Reliance Manager will also be responsible for ensuring regulatory and institutional compliance in the execution of reliance agreements between the University of Minnesota and external research entities. The Reliance Manager will ensure that non-SMART IRB agreements are comprehensive and that all agreements are in compliance with relevant regulations and guidelines governing human subjects research. This position requires strong organizational, communication, and negotiation skills, as well as a comprehensive understanding of IRB processes and regulations. The position requires a level of independence and is expected to escalate problems with potential solutions to HRPP leadership when appropriate. This position will also supervise the Senior IRB Analyst for Reliance/sIRB. This position reports to an Assistant Director.

Position Duties and Responsibilities

IRB Reliance Agreements - 30%
Lead and manage the negotiation, development, and execution of reliance agreements between our institution and external research entities for both reliance upon an external IRB and serving as the IRB of record.
Ensure that the University of Minnesota is complying with the responsibilities identified in reliance agreements (reporting, communications, etc).
Manage institutional worksheets for the University of Minnesota (NCI CIRB, NMDP, SMART IRB, etc). Works with HRPP leadership regarding conflicting policies or requirements, as appropriate.
Serve as the primary point of contact for all external parties involved in the reliance agreement process.
Works with HRPP leadership regarding complex matters that require additional leadership support or action.

Ensure Compliance - 25%
Ensure that all reliance agreements comply with institutional policies, as well as federal, state, and local regulations governing human subjects research.
Collaborate with regulatory and compliance teams to address any compliance issues or concerns related to reliance agreements.
Evaluate reportable events submitted for ceded research and prepare recommendations for local institutional considerations to HRPP leadership for discussion.
Provide regulatory support for reporting sIRB related matters to regulatory agencies under the supervision of HRPP leadership.

Maintain Documentation - 15%
Ensure that all documentation is accurate and up-to-date regarding all reliance agreements, correspondence, and related documentation.
Maintain standardized templates and tools for the negotiation and management of reliance agreements.

Monitor and Evaluate Processes -15%
Monitor the effectiveness and efficiency of reliance agreement processes and procedures.
Identify areas for improvement and implement enhancements to streamline and optimize the reliance agreement process.

Stay Informed - 10%
Stay informed about changes and updates to regulations, guidelines, and best practices related to IRB reliance agreements.
Attend relevant conferences, workshops, and training sessions to stay current in the field of human subjects research compliance.

Provide Guidance and Training - 5%
Provide supervision for, including guidance and support to the Sr. IRB Analyst.
Provide consultative support to the University of Minnesota IRB when serving as the single IRB (sIRB) as needed.
Provide consultative support to investigators and research teams regarding the establishment and maintenance of reliance agreements.
Lead and manage the development and facilitation of training sessions and workshops to educate stakeholders about reliance/sIRB processes, procedures, and best practices, in collaboration with the Sr. IRB Analyst and HRPP leadership (as needed).

The Research and Innovation Office (RIO) and HRPP endorses a "work with flexibility" approach that offers a welcoming and flexible work environment where everyone is inspired to do their best. Work location options include working fully remote, partially remote, or entirely in the office and are based on the work of the position. Some on-site work may be necessary for certain positions, even those designated as fully remote.

This position has been designated as eligible for RIO flexible work profile four. Profile four is expected to work fully remotely with the exception of required attendance for on-site events. Your dedicated work space will be in your remote work location. HRPP retains the right to modify flexible work arrangement agreements on a temporary or permanent basis for any reason at any time

Required Qualifications
Bachelor's degree in a related field (e.g., health sciences, regulatory affairs, public health)
Minimum of six years of experience working in human subjects research administration.
Comprehensive understanding of federal regulations (e.g., 45 CFR 46, FDA regulations) and ethical principles governing human subjects research.
Strong communication, negotiation, and interpersonal skills.
Excellent organizational skills and attention to detail.
Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.
Proficiency in Microsoft Office Suite and other relevant software applications.

Preferred Qualifications
Advanced degree or JD strongly preferred
Certified IRB Professional (CIP), or similar credential.
Five years of specific experience in IRB reliance administration.
Experience working with electronic IRB management systems (e.g., Click, IRBNet, iRIS).

The mission of the University of Minnesota is deeply connected to the conduct of research. It is of critical importance to the reputation and future of this institution that we remain committed to the highest standards of research integrity in all work conducted in our institution.

The Human Research Protection Program (HRPP) provides support to the Institutional Review Board (IRB). Committee members and staff review all human subjects research conducted by University faculty, staff and students. HRPP also provides support to the research community to ensure ethical standards are met and that research complies with federal, state, local and University of Minnesota regulations.

The IRB reviews human subjects' research projects, working with investigators to ensure adequate protection and informed, uncoerced consent.

Pay Range: $90,000-$94,000; depending on education/qualifications/experience

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will have the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section. Attach a cover letter with your application.

This position will remain open until filled.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds. HRPP is committed to the University's goal of creating a positive and inclusive environment by advancing equity and diversity.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).