The Minneapolis Heart Institute Foundation® (MHIF) is seeking a Compliance, Quality & Regulatory Specialist II 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 entering our 40th year, MHIF is recognized globally as a research leader in the broadest range of cardiovascular medicine with cutting-edge science centers.
We are seeking solution-oriented candidates committed to making a difference and who bring a high level of integrity, initiative, flexibility, and a positive attitude. In this role, you will serve as an Institutional Review Board (IRB) and regulatory subject-matter resource. You will act as a liaison between MHIF, industry sponsors and the various IRBs MHIF partners with by securing IRB approval for new research studies and ensuring effective and timely reporting and exchange of regulatory correspondence. Under the direction of the CQR Manager, the CQR Specialist II supports and participates in internal quality monitoring of research studies and helps manage policies and Standard Operating Procedures (SOPs) and compliance needs across the organization.
Serves as an expert resource to research study staff and investigators in the interpretation and application of internal and external IRB reporting requirements, and applicable Health Insurance Portability and Accountability Act (HIPAA) and Food and Drug Administration (FDA) regulations.
Assists the Scientific Services team in the development and editing of investigator-initiated study protocols to meet IRB requirements and policies as well as HIPAA and FDA regulations. Consults with external entities and MHIF partners on regulatory requirements and IRB applications for investigator-initiated studies.
Communicates directly with study sponsors in collecting, preparing, editing, and submitting IRB applications, regulatory documentation, reports, and correspondence.
Communicates regularly on status of startup and ongoing regulatory duties with research study staff, sponsors, IRBs, and other stakeholders.
Updates and maintains a study database with essential information on all MHIF studies.
Files, stores, maintains, and tracks regulatory applications, documents, and research study information in accordance with regulatory standards and MHIF processes and SOPs.
Creates and improves upon guidelines, tools, and processes to support high-quality regulatory and compliance work.
May direct activities of and provide informal guidance, education, and training to CQR Administrative Assistant and CQR Specialist I.
Assists the Sr. Director, CQR in the management and oversight of research- and non-research-related potential conflicts of interest in accordance with MHIF policies and SOPs.
Leads and assists with management and oversight of MHIF policies and SOPs.
Works with cross-functional teams and provides regulatory input and solutions.
Assists with education and training of MHIF employees related to applicable research and compliance topics and regulations.
Participates in monitoring and auditing selected research projects to ensure compliance with applicable internal, federal, and state regulations.
Supports and assists Sr. Director, CQR with non-research compliance needs and special projects and initiatives as needed.
Works collaboratively with all MHIF employees as part of a positive, supportive culture.
This position reports to the CQR Manager and may also take work direction from the Sr. Director, CQR. The CQR Specialist II works closely with MHIF research staff and with other key internal and external stakeholders.
3-5 years of experience working with regulations, including specifically Food and Drug Administration (FDA) and HIPAA, governing the conduct of research.
3 years of experience supporting investigator-initiated research (may be concurrent with the above).
Demonstrated strong interpersonal and written communication skills.
Advanced skills in MS Word and intermediate skills in database programs, including MS Excel, Outlook and SharePoint.
Ability to think critically, exercise sound independent judgment, adapt to an evolving internal and external regulatory environment, and manage competing priorities.
Recognize problems or situations that are new or do not have clear precedent. Evaluate alternatives and find solutions that fall within MHIF and IRB policies and applicable regulations.
Ability to work with others as a team and in support of a positive work culture.
General knowledge of common cardiovascular medical terminology.
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.
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.
Heart and vascular disease remain the leading cause of death worldwide. We are committed to ending this. Every year we make new discoveries through research and we share our findings to improve the lives of patients worldwide. For 40 years, MHIF has been one of the leading nonprofit cardiovascular and vascular research and education institutions in the country with over 200 active research studies and publications ongoing each year.