Regulatory Affairs Analyst - Grand Rapids, MI

Job Summary

Responsible for all activities in support of the Human Research Protection Program (HRPP) by facilitating and participating in the regulatory review of human subject's research conducted under the jurisdiction of the Corewell Health’s HRPP. Provides regulatory support and oversight for the Research Community and serves as a point of contact for submission inquiries and requests for guidance and consultation as it pertains to the federal regulations, state and local laws, as well as Corewell Health Policies governing human subject’s research. Ensures that Corewell Health's human research activities are conducted in compliance with institutional standard operating procedures (SOPs) and international, federal, state, and local rules and regulations and ethical principles regarding human subject research. May serve as an official member of the Institutional Review Board (IRB) Committee and/or a "designated" reviewer, as applicable.

Essential Functions

• Assists and guides investigators through the application submission process. Interprets and advises investigators on applicable policies, procedures, guidelines, federal regulations, and other compliance related requirements. Functions as a liaison within and between the IRB committee, investigators and their designees, and other research support staff.
• Ensures timely processing, review, and disposition of research applications within established expectations and SOPs.
• Serves as an official member of the IRB Committee and/or a “designated” reviewer, as applicable.
• Serves as the lead for the assigned team and provides guidance and mentorship across the department regarding complex HRPP issues/situations
• Responsible for maintaining the security and integrity of federally and contractually mandated regulatory data assuring comprehensive and compliant IRB documentation and records in accordance with regulations and SOPs. Responsible for the maintenance and retention of all required IRB records, communications, and other files for assigned submissions.
• Possesses a comprehensive and broad understanding and knowledge of federal and state regulations, state and local law and IRB SOPs. Develops SOPs and policies for the HRPP to include topics such as IRB Operations, Overarching special topic guidance sheets, HIPAA in relation to research and Conflicts of Interest in research.
• Assists with the conduct of HRPP Post Approval Monitoring activities as required by federal regulations and local SOPs. Develops and implements effective HRPP educational strategies.

How Corewell Health cares for you

• Comprehensive benefits package to meet your financial, health, and work/life balance goals. Learn more here.
• On-demand pay program powered by Payactiv
• Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more!
• Optional identity theft protection, home and auto insurance, pet insurance
• Traditional and Roth retirement options with service contribution and match savings

Qualifications

Required

• Required Bachelor's Degree or equivalent preferred areas of study include clinical, life or social sciences

• 2 years of relevant experience IRB administration, clinical research or other human subject protection-related job or other analytical or compliance Required

Preferred

• Preferred Master's Degree

• direct and obvious relevance to regulatory compliance and/or research with human subjects Preferred
• Relevant program/project management Preferred

About Corewell Health

As a team member at Corewell Health, you will play an essential role in delivering personalized health care to our patients, members and our communities. We are committed to cultivating and investing in YOU. Our top-notch teams are comprised of collaborators, leaders and innovators that continue to build on one shared mission statement - to improve health, instill humanity and inspire hope. Join a nationally recognized health system with an ambitious vision of continued advancement and excellence.