Join the Minneapolis Heart Institute Foundation and make an impact as an Administrative Assistant, enabling the success of our regulatory team!
Now in its 39th year, MHIF is one of the leading non-profit cardiovascular and vascular research and education institutions in the country. We exist to create a world without heart disease and our mission is to improve people’s lives through the highest quality cardiovascular research and education. Staffed with over 80 high caliber employees, we conduct cutting-edge clinical research and transformative community research.
We are seeking candidates committed to making a difference, bring their high level of integrity, initiative, flexibility, organization skills and positive attitude. In this role, you will organize and execute meetings, projects, and interface with regulatory staff, MHIF leadership, and other staff members to ensure a seamless experience. Additionally, in this high impact role, the individual helps to support regulatory and compliance functions through general administrative support and by preparing regulatory submissions, documents, and presentations. Reporting to the IRB and Regulatory Manager, you will also collaborate with the Research and administration teams and across MHIF.
- Regulatory Support
- Secures and maintains study-related documentation from investigators and other study personnel on a by-study, as-needed basis
- Prepares basic submissions (personnel changes, continuing review) to the Institutional Review Board (IRB) under the guidance of the Manager, IRB & Regulatory
- Manages administrative work processes and documentation for the regulatory function, including management of regulatory SOPs and work standards
- Assists with regulatory binder management
- Routinely interfaces with research coordinators and managers in support of the function
- Study Personnel Management
- Develops and maintains a comprehensive tracking mechanism for all study personnel and investigator training, education and certification-related information and documentation
- Facilitates distribution of routine training reminders
- Maintains current licenses, CVs, bio-sketches, and other documentation, as applicable, for all study personnel
- Assists with conflict of interest management documentation
- General Administrative Support
- Assists in coordination of clinical monitoring visits
- Provides support for projects as needed
- Assists in scheduling meetings, preparing agendas/documents, meeting minutes
- May validate regulatory review-related invoices for finance
- Provides back up as needed for other administrative staff including research office coordinator
- Assists with management of off-site storage
- Assists with general data entry, running general reports and metrics
The Administrative Assistant reports to the Manager, IRB & Regulatory and works closely with the IRB & Regulatory Specialist. This position interacts regularly with MHIF staff and investigators.
- High school diploma or GED.
- Minimum three years of administrative experience.
- Proven track record of successfully managing complex tasks and balancing multiple priorities.
- Proficient in Microsoft Office, including Word, Excel and PowerPoint.
- Critical attention to detail and work accuracy.
- Ability to appropriately handle confidential and sensitive information.
- Strong interpersonal skills with the ability to work with others as a team and in support of a positive work culture.
- Additional education beyond high school.
- Experience in a research environment.
- Experience with or exposure to research- or healthcare compliance-related regulations.
PHYSICAL REQUIREMENTS NECESSARY TO PERFORM THIS JOB:
- Must be able to work at a computer for extended periods of time
- Work in a cubicle in a typical office setting
Join our talented 80+ person team:
Minneapolis Heart Institute Foundation is an EEO/Affirmative Action employer.
Date posted: August 4, 2021