Job Posting: Quality and Regulatory Manager
The Minneapolis Heart Institute Foundation® (MHIF) is seeking a Quality 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 41st year, MHIF is recognized globally as a research leader in the broadest range of cardiovascular medicine with cutting-edge science centers.
This is an exciting growth opportunity for an experienced IRB or regulatory professional interested in building out and developing a robust research quality function in addition to overseeing ongoing submission and regulatory work. In support of the Minneapolis Heart Institute Foundation (MHIF) mission, the Quality and Regulatory Manager oversees the Quality & Regulatory Specialist staff who work integrally with MHIF research teams and serves as 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 contributing to research education and training and/or supporting quality activities outside the research portfolio.
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.
- Provides leadership and supervision to the Quality and Regulatory Specialists, including coaching, performance management and staff development.
- With Vice President, develops, contributes to and supports functional area strategic planning and continuous process improvement activities to align with MHIF goals.
- Provides Vice President 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 Vice President, 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.
This position reports to the Vice President, Compliance, Quality & Regulatory. The incumbent consults with the Vice President of Research Operations, Sr. Director of Scientific Services and others 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.
- Demonstrated readiness to assume a leadership role (e.g. had direct supervisory experience or provided direction to other staff, assumed interim leadership role, led individual projects, etc.)
- 3-5 years of experience in research with a deep understanding of the clinical research and IRB oversight processes
- Working knowledge of applicable FDA, IRB and HIPAA regulations and guidance, ICH GCP standards, etc.
- Ability to think critically, exercise sound independent judgment, adapt to an evolving internal and external regulatory environment, and manage competing priorities
- Recognizes problems or situations that are new or do not have clear precedent; evaluates alternatives and finds solutions that fall within applicable policies and regulations
- Strong interpersonal and influence skills with the ability to work with others as a team and in support of a positive work culture across enterprise and cross-functional
- Proficiency using technology to support routine office and specialized research functionality
- Bachelor’s degree
- Previous supervisory or other leadership experience
- Certification in clinical research, IRB, or healthcare compliance (including but not limited to CCRA, CCRC, ACRP-CP, or CIP) or willingness to secure certification within one year of hire
- Cardiovascular research experience or general knowledge of common cardiovascular medical terminology
- Experience auditing or monitoring research
- Experience developing and delivering educational content
Ability to work at a computer for long periods of time.
This job description represents the major functions of the position but is not intended to be all-inclusive. Position requires in-office time but has some flexibility for remote work.
Apply to join our talented 90+ person team:
Minneapolis Heart Institute Foundation is an EEO/Affirmative Action employer.
Date posted: January 17, 2023