The Minneapolis Heart Institute Foundation® (MHIF) is seeking a Compliance, Quality & Regulatory Specialist I 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 provide regulatory and compliance assistance to research teams and the organization as a whole. Under the direction of the CQR Manager and CQR Specialist II, this position is responsible for managing certain Institutional Review Board (IRB) submissions and IRB reporting, for the organization and management of assigned regulatory documents and processes, for supporting investigator-initiated chart review studies, and providing assistance with other regulatory or quality work as needed.
- Provides regulatory assistance to the CQR function and to research teams by collecting, preparing, editing and managing IRB submissions, regulatory documentation, reports and correspondence.
- Updates and maintains a study database with essential information on all MHIF studies.
- Assists with adapting or editing informed consent forms.
- Files, stores, maintains and tracks regulatory documents and research study information in accordance with regulatory standards and MHIF processes and Standard Operating Procedures (SOPs).
- Communicates regularly with research study staff and other stakeholders regarding the status of startup and ongoing regulatory duties.
- Participates in monitoring selected research projects to ensure compliance with applicable internal, federal and state regulations.
- Manages specific regulatory or compliance processes as directed.
- Works collaboratively with all MHIF employees as part of a positive, supportive culture.
This position reports to the CQR Manager but may also take direction from the CQR Specialist II and Sr. Director, CQR. The CQR Specialist I works closely with MHIF research and other staff, IRBs, and other internal and external stakeholders.
- High School Diploma or GED. At least some post-secondary coursework preferred.
- Two years of experience working with regulations governing research or other healthcare activities or 3+ years’ experience working in another highly regulated environment.
- Strong interpersonal and written communication skills.
- Advanced skills in MS Word.
- Ability to exercise sound independent judgment and to manage competing priorities.
- Ability to work with others as a team and in support of a positive work culture.
- Bachelor’s Degree in a related field.
- Familiarity with research or healthcare terminology.
- Experience using electronic systems to manage work processes and information.
- Certification in clinical research or human subject protection.
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.
Join our talented 80+ person team:
Minneapolis Heart Institute Foundation is an EEO/Affirmative Action employer.
Date posted: November 23, 2021