The Minneapolis Heart Institute Foundation® (MHIF) is seeking an IRB and Regulatory Manager to contribute to MHIF’s vision of creating a world without heart and vascular disease. To achieve this bold vision, we are dedicated to improving the cardiovascular health of individuals and communities through innovative research and education. Now in its 38^th year, MHIF is recognized globally as a research leader in the broadest range of cardiovascular medicine with cutting-edge science centers.

Job Summary:
In support of the Minneapolis Heart Institute Foundation (MHIF) mission, the IRB and Regulatory Manager oversees the IRB & Regulatory Specialist staff who work integrally with MHIF research teams and serves an Institutional Review Board (IRB) and regulatory subject-matter resource. The Manager acts as a liaison between MHIF, industry sponsors and the various IRBs that MHIF partners with, secures IRB approval for new research studies, and ensures effective and timely reporting and exchange of regulatory correspondence and metrics related to the multitude of research studies performed by MHIF. Dependent upon interest, experience, and need, the Manager may also have growth/development opportunities such as oversight of quality monitoring or contributing to research education and training.

Individual Contributor Responsibilities

• Serves as an expert resource to research study staff and investigators in the interpretation and application of IRB requirements, the Health Insurance Portability and Accountability Act (HIPAA), Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines and MHIF Standard Operating Procedures (SOPs).
• Provides regulatory assistance to the research teams by collecting, preparing, editing and submitting IRB applications, consent forms, regulatory documentation, reports and correspondence.
• Updates and maintains a study database with essential information on all MHIF studies.
• Communicates regularly with research study staff, sponsors, IRBs and other stakeholders regarding the status of startup and ongoing regulatory duties.
• Works collaboratively with MHIF leadership and employees as part of a positive, supportive culture.

Manager/Oversight Responsibilities

• Provides leadership and supervision to the IRB and Regulatory Specialists, including coaching, performance management and staff development.
• With Sr. Director, develops, contributes to and supports functional area strategic planning and continuous process improvement activities to align with MHIF goals.
• Provides Sr. Director with routine metrics, analysis and reporting related to regulatory and compliance functions and works collaboratively on potential solutions to address concerns or areas of potential risk.
• Leads efforts to assess potential expansion of regulatory staff role and assists in development, change management around and implementation of any expansion.
• Scans, evaluates and translate for implementation changes in applicable laws, regulations, guidance, Federal agency expectations and national practice standards.
• Creates and improves upon SOPS, guidelines, tools, and processes to support high-quality IRB and regulatory work and general research compliance. Partners with Research Operations, Scientific Services and others in the development and maintenance of operational SOPs.
• Assists in monitoring and auditing selected research projects on an as needed basis to ensure compliance with applicable internal, federal and state regulations.
• Delivers routine educational and training content to research staff on an as-needed basis.
• May participate in MHIF Emerging Leaders opportunities as available and appropriate.

Potential Additional Opportunities

• Develops, oversees and delivers robust initial and continuing training and education for investigators and staff on matters such as regulatory compliance, HIPAA, GCP guidelines, and inspection-readiness. Participates in new research staff onboarding and competency standard development and maintenance.
• With Sr. Director, develops and implements robust, multi-faceted internal quality monitoring program, to include creation of tools, strategic plan and routine metrics and reporting.
• Other opportunities for significant, high-level contribution may be available dependent upon candidate interest and experience and program need.

Relationships: 

• This position reports to the Sr. Director, Compliance, Quality & Regulatory. The incumbent consults with the Vice President of Research Operations and Director of Scientific Services on the prioritization of new study submissions and associated timelines. The Manager works closely with MHIF research managers, staff, internal and external IRBs and key Allina Health stakeholders and partners.