Responsible for operation of the Institutional Review Board (IRB) activities in a manner consistent with department and institutional policies and goals; as well as, federal regulation and guidance. Supervises IRB staff conducting review and/or approval of human subject research, including: workload assessment and distribution, delegation of special projects and initiatives, coordinate and facilitate regular meetings with staff, performance management via performance appraisals and one-to-one meetings, guides staff in establishing and pursuing goals for professional development. Serve as a key member of the leadership team with a primary administrative leadership, management of allied health staff, program budget development and oversight, operational and strategic planning, and implementation of policies and systems. Performs duties independently and initiates judgment in handling a variety of management issues. Direct reports include research employees in assigned work groups of the IRB. Represents the IRB with internal and external customers as assigned by Operations Manager. Is first point of contact in communicating with customers when problems arise. Organizes and provides ongoing training and education support for staff, while encouraging an atmosphere of career development and professional support. Provides consultation to and receives input on changes to or clarification of policy and procedure; implements changes as needed.
Responsible for consistent application of regulation, guidance, quality of service, strategic planning and continuous improvement. Maintains high level of technical competence and confidence (e.g IRBe) to apply knowledge in all types of Human Subject Research. Must be adaptable, flexible, creative, dependable, responsible and able to perform within a changing environment. Works with Operations Manager to develop policy as directed by regulation or internal needs.

*This is a 100% remote position 

A Bachelor's degree in Business, Health Care Administration, Public Administration, or related field with at least 5 years of relevant Human Subject Research experience is required, or a Master's degree with at least 3 years of relevant Human Subject Research experience. Expertise of Institutional Review Board policy and procedures, Office of Human Research Protection and Food and Drug Administration Code of Federal Regulations, and International Conference on Harmonization – Good Clinical Practice Guidelines and internal and external IRB policy and procedures required. Must have demonstrated leadership, excellent communication, problem solving and organizational abilities. Must be highly organized, efficient and able to work independently. Requires interpersonal skills to educate, influence and motivate others. Work is directed by operations manager, incumbent must be able to take initiative and work independent under stressful situations. Candidate must possess the ability to manage several projects or tasks simultaneously and to exercise judgment when prioritizing projects.
Mayo Clinic Quality Academy Bronze certification or comparable Quality or Lean methodology certification preferred or related areas is preferred.Certification in applicable regulatory, compliance and/or research area preferred (e.g., CCRP, CCRA, CCRC, RAC, CIP).