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 bringing more treatments to all patients 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.
The Research Compliance Specialist Senior role is located within the MICHR IND/IDE Investigator Assistance Program (MIAP), and was established to provide comprehensive regulatory support, guidance, and education services to faculty investigators involved in US FDA regulated clinical research at UM. MIAP's primary focus is to offer regulatory assistance to sponsor-investigators of a new drug, biologic or medical device to ensure clinical research excellence and regulatory compliance, as set forth by the UM and the FDA.
Note: This position is hybrid, with occasional travel to Ann Arbor, MI required. Remote work options will also be considered.
80% Regulatory Project Management:
Responsible for the preparation and submission of IND?s and IDE?s and related submissions including preparation of meeting packages, responses to FDA inquires and life-cycle maintenance submissions to FDA Critically review submission documents and clinical trial documents such as clinical protocols and informed consent documents to ensure compliance with regulatory requirements Assist with developing and providing regulatory and operational guidance and support to investigators by interacting with project teams Responsible for the preparation and submission of expanded access requests for investigational drugs and devices 15% Education and Consultations:
Provide regulatory expertise and support to the UM Institutional Review Board Assist in providing regulatory education and training to investigators, sponsor-investigators, clinical research monitors and other research/regulatory personnel Provide guidance and support to investigators and study teams related to regulatory issues in product development 5% Medical Writing and Editing:
Creating and revising SOPs, development of tools, documents and resources for the purposes of creating standard practice, templates and education/training materials Reviews manuscripts/posters presentations/abstracts as appropriate Bachelor?s degree in a scientific or technical discipline 5 years or more of professional experience in research compliance or FDA regulated research administration or equivalent in educational training and background Knowledge of the FDA regulations, policies and guidance related to investigational drugs and devices Considers all relevant factors and uses appropriate decision-making criteria and principles Attention to detail Able to work independently and responsibly with minimal supervision Works cooperatively with others across the organization to achieve shared objectives Is effective in a variety of communication settings: one-on-one, small, and large groups, or among diverse styles and position levels Sophisticated medical terminology competence 2-5 years' experience in the regulatory field, specifically in the submission of INDs and IDEs Demonstrates and ensures a high level of competency and compliance with University policies and Federal Regulations Regulatory Affairs Certification (RAC) Day Shift
MICHR is firmly committed to advancing Inclusion, Diversity, Equity, Accessibility, and belonging which are core values at the Office of Research. Our community supports recruiting and cultivating a diverse workforce, as it reflects our commitments to serve the diverse people of Michigan. We strive to create a work culture where every team member feels respected, valued, and safe.
Under FLSA, this is the exempt job classification for this title. Incumbents in this position must meet the full criteria for exempt status: salary level, salary basis, and duties tests.
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.
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