A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
The Michigan Institute for Clinical & Health Research (MICHR) is the home of the University of Michigan's Clinical and Translational Science Award from the National Institutes of Health. MICHR is part of a national, collaborative consortium that is focused on delivering more treatments to all people more quickly by advancing clinical and translational science (CTS). The field of CTS aims to build an evidence base of scientific and operational approaches that improve the efficiency, effectiveness, and impact of translational research across a range of diseases and conditions. MICHR has the unique charge of examining the translational research ecosystem at a systems level to determine where common pitfalls exist; developing novel solutions to these challenges; demonstrating their effectiveness; and disseminating improvements widely. MICHR is a dynamic organization that serves as a hub of innovation and experimentation to advance research in the science of translation and accelerate the realization of interventions that improve human health.
MICHR is seeking a Research Compliance Specialist Lead to provide leadership, mentorship, and advanced regulatory expertise within the IND/IDE Investigator Assistance Program (MIAP). This position provides regulatory consultation, education, training, and FDA liaison support to University of Michigan investigators conducting FDA-regulated clinical research involving investigational drugs, devices, and biologics.
The individual in this role will possess advanced technical expertise in FDA regulatory requirements and sponsor-investigator responsibilities, including management of IND and IDE submissions and maintenance activities. The position also provides functional leadership and mentorship to MIAP staff, supports operational initiatives, quality improvement activities, development of SOPs and educational resources, and institutional regulatory compliance efforts. Additional responsibilities include collaborating with internal regulatory and research support partners and serving as a subject matter expert on FDA-regulated clinical research and sponsor-investigator responsibilities.
50% Leadership, Mentorship & Program Operations
Provide functional leadership, mentorship, onboarding, and training to MIAP Research Compliance Specialists
Assist Program Director with development and implementation of operational initiatives and strategic program activities
Identify programmatic strengths and improvement opportunities and collaborate on continuous quality improvement initiatives
Lead development, implementation, and maintenance of SOPs, templates, tools, and standard practice documents
Support operational consistency, quality assurance, and regulatory best practices across MIAP activities
Serve as a liaison to internal partners to support efficient operational workflows, as assigned by Program Director
40% Regulatory Submissions, FDA Communication & Consultation
- Manage and oversee UM Sponsor-Investigator FDA regulatory activities for clinical research involving investigational drugs, devices, and biologics, including INDs and IDEs
- Author, prepare, and contribute to FDA submissions including INDs, IDEs, pre-submissions, meeting requests, responses to FDA inquiries, amendments, annual reports, and lifecycle maintenance submissions
- Communicate directly with FDA regarding regulatory submissions
- Provide regulatory guidance, consultation, and strategic support to UM sponsor-investigators and study teams
- Critically review clinical protocols, informed consent documents, eResearch applications, and related materials to ensure compliance with applicable regulations and institutional requirements
- Collaborate with IRBMED, CTSU, ORSP, Regulatory Affairs, Office of General Counsel, and research consortiums to support coordinated regulatory oversight
- Monitor and interpret evolving FDA regulations, guidance documents, and enforcement trends and communicate relevant updates to stakeholders
- Provide regulatory guidance and consultation on FDA regulations for internal units, such as Institutional Review Board (IRB), Human Research Protection Program (HRPP) related units, Clinical Trials Support Units, Regulatory Affairs, Office of General Counsel and others as needed, including eResearch review for applicable drug/device/biologic applications
- Assist in providing regulatory education and training to investigators, sponsor-investigators, monitors and other research/regulatory personnel
- Provide guidance and support to investigators and study teams related to regulatory issues in product development
- Works with other program staff, developing and presenting educational materials
- Serve as subject matter expert for applicable FDA regulations and interactions for the institution
- Collaborate with program director and other research/regulatory personnel to develop CAPA plans for institutional compliance concerns
10% Education and Consultation
- Provide regulatory guidance and consultation on FDA regulations for internal units, such as Institutional Review Board (IRB), Human Research Protection Program (HRPP) related units, Clinical Trials Support Units, Regulatory Affairs, Office of General Counsel and others as needed, including eResearch review for applicable drug/device/biologic applications
- Assist in providing regulatory education and training to investigators, sponsor-investigators, monitors and other research/regulatory personnel
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