In support of the research studies and operations of the Minneapolis Heart Institute Foundation (MHIF), the Regulatory Specialist II is responsible for serving as an Institutional Review Board (IRB) and regulatory subject-matter resource, as a liaison between MHIF, industry sponsors and the various IRBs that MHIF partners with, securing IRB approval for new research studies, and ensuring effective and timely reporting and exchange of regulatory correspondence related to the multitude of research studies performed by MHIF.
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 Managing Scientist, Sr. Biostatistician, investigators and staff 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.
Provides regulatory assistance to the research teams by collecting, preparing, editing and submitting IRB applications, regulatory documentation, reports and correspondence.
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 Standard Operating Procedures (SOPs).
Communicates regularly with research study staff, sponsors, IRBs and other stakeholders regarding the status of startup and ongoing regulatory duties.
Drafts and modifies data use agreements to comply with applicable HIPAA regulations.
Creates and improves upon guidelines, tools, and processes to support high-quality IRB submission and record-keeping.
May provide informal guidance, education, and training to Regulatory Administrative Assistant.
Leads and assists with regulatory SOPs and process mapping.
Works with cross-functional teams and provides regulatory input and solutions.
Participates in monitoring and auditing selected research projects to ensure compliance with applicable internal, federal and state regulations.
Assists with adapting or editing informed consent forms.
Works collaboratively with all MHIF employees as part of a positive, supportive culture.
This position reports to the Director, Compliance, Quality and Regulatory Affairs. The incumbent consults with the Director of Research Operations and Research Operations Systems Manager on the prioritization of new study submissions and associated timelines. The Regulatory Specialist II also works closely with MHIF research staff, and internal and external IRBs.
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 experience).
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.
Additional Salary Information: We offer a very generous salary and benefits package
Internal Number: 1121
About Minneapolis Heart Institute Foundation
The Minneapolis Heart Institute Foundation® (MHIF) has a 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 36th year, MHIF is a recognized research leader in the broadest range of cardiovascular medicine and population health initiatives. Each year MHIF leads more than 175 active research projects and publishes more than 120 peer-reviewed studies. And MHIF leads cutting-edge, transformative population health research to connect, engage, inform and empower individuals and communities to improve their health. MHIF provides an excellent opportunity to contribute in high impact roles with unique, stimulating and varied work.
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