Research Compliance Specialist Senior

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 Senior role located within the MICHR IND/IDE Investigator Assistance Program (MIAP).  MIAP was established to provide comprehensive regulatory support, guidance, and education services to faculty investigators involved in US FDA regulated clinical research at the University of Michigan (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, including the preparation and submission of FDA IND and IDE applications. 

80% Regulatory Project Management:

• Responsible for the preparation and submission of IND's and IDE's or IND Exemption requests or Device Risk Determination Requests
• Prepare and contribute to IND and IDE filings 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
• Demonstrates and ensures a high level of competency and compliance with university policies and Federal Regulations
• Collaborate with the IRB, CTSU, ORSP or research consortiums (i.e. HCRN, Big Ten CRC), to ensure coordinated regulatory oversight.
• Monitor and interpret changes in FDA regulations and guidance documents; effectively communicate relevant updates to internal and external stakeholders to ensure ongoing compliance.

15% Education and Consultations:

• Provide regulatory expertise and support to the UM Institutional Review Board, including eResearch review for applicable drug/device/biologic applications
• Active Membership in national regulatory support professional organizations.
• 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

Required Qualifications

• 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

Preferred Qualifications

• 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)