<p>The Institutional Review Board (IRB) Manager provides leadership support for the Human Research Protection Program (HRPP); is responsible for oversight of IRB Analysts; and serves as a liaison between the Assistant Director and IRB operations staff. The IRB Manager has the primary responsibility for managing a team of IRB Analysts and overseeing the activities that support committee and non-committee review of IRB submissions. This includes managing team workload, monitoring team productivity and processing turnaround times, and ensuring that IRB staff and panel members are utilizing the UMN HRPP Toolkit appropriately.<br /><br />The IRB Manager is responsible for providing feedback and suggestions to the Assistant Director regarding the use of the UMN HRPP Toolkit. The IRB Manager also serves as a member/alternate on the IRB and is a regulatory specialist designated to conduct non-committee reviews of research involving human subjects. This position depends on a strong knowledge of federal, state, and institutional regulations that govern the use of human subjects in research. As such, IRB Managers rely on this knowledge to provide IRB staff and committee support. It is detailed work that has a great deal of scrutiny from everyone from federal regulators to university Regents to state auditors. <br /><br />Essential Functions:<br />1. Oversee IRB Team Operations 40%</p><ul><li>Assure that the IRB panel(s) and staff comply with the UMN HRPP Toolkit which includes applicable local and federal regulations, rules, guidelines and ethical principles</li><li>Perform duties as specified in the UMN HRPP Toolkit</li><li>Triage and assign submissions to IRB Analysts</li><li>Oversee IRB reviewer assignments and attendance to ensure appropriate expertise is present/available</li><li>Work with other IRB Managers to coordinate activities as needed</li><li>Conduct quality assurance reviews for IRB meeting minutes and general post-review correspondence</li><li>Assist with training of new IRB members and serve as a contact for member questions/concerns for assigned panel(s)</li><li>Monitor IRB staff productivity metrics and goals</li><li>Identify and address workflow issues as they arise so that quality and efficiency are optimally maintained</li><li>Investigate and answer regulatory questions from research community, including phone calls, emails and in person requests</li><li>Conduct HRPP related training as needed</li><li>Interpret and apply federal regulations and any relevant state law to research submissions at all stages of HRPP review</li><li>Solve problems, conditions, circumstances that necessitate knowledge of regulations, guidelines, rules, ethical principles with enterprise and new approaches<br /> </li></ul><p>2. IRB Staff Management 30%</p><ul><li>Directly supervise IRB Analysts on assigned team</li><li>Hold regularly scheduled staff meetings</li><li>Provide guidance regarding coordination and communication of the regulatory functions of HRPP</li><li>Evaluate IRB staff performance to include assessing quality, productivity, and efficiency and provide ongoing feedback</li><li>Ensure supervision of staff conforms to bargaining unit requirement, Civil Service work rules and University Human Resources policies</li><li>Evaluate work volume: staff ratio and make recommendations to HRPP leadership when changes are required</li><li>Assign work, reward, discipline, and direct the work of both full-time and part-time IRB staff University employees</li></ul><p>3. Perform IRB Reviews 20%</p><ul><li>Serve as an IRB member/alternate, as well as a designee of the Chair to conduct expedited review</li><li>Attend convened IRB meetings and perform reviews as needed</li><li>Perform non-committee reviews of IRB submissions</li></ul><p>4. HRPP Support and Development 10%</p><ul><li>Conduct presentations related to regulatory/human subjects protection topics or IRB process for groups or classes involved in the conduct of human subject research</li><li>Participate in the development and conduct of training on IRB-related issues for HRPP staff and IRB members</li><li>Attend regional and national conferences to pursue ongoing professional education and stay current on federal regulations, guidance and accreditation standards</li><li>Provide support for HRPP leadership as needed</li><li><span style="font-family:calibri,sans-serif;"><span style="font-size:11.0pt;">Attend meetings as needed with other University entities to collaborate and to address human subject protection issues</span></span></li></ul>
<p><strong>Required qualifications:</strong><br /><br />Bachelor of arts or science degree<br />3-5 years' experience working in an HRPP for both biomedical and social and behavioral research<br />3-5 years' direct supervisory experience to include managing workload, monitoring productivity and turnaround times<br />Thorough knowledge of federal regulations that apply to human subjects research and critical thinking skills to apply that knowledge<br />Ability to maintain poise and grace under pressure<br />Well-honed communication skills<br />Strong organizational and problem solving skills<br />Certified IRB Professional (CIP) certification within one year of hire</p><p><br /><br /><strong>Preferred qualifications: </strong><br /><br />Experience with the Huron or Western IRB Toolkit<br />Certified IRB Professional (CIP) certification</p>
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.