PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
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 Spectrum Health 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 Spectrum Health Policies governing human subjects research. Ensures that Spectrum 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.
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.
Bachelor's Degree or equivalent preferred areas of study include clinical, life or social sciences, Required
Master's Degree, Preferred
2 years of relevant experience IRB administration, clinical research or other human subject protection-related job or other analytical or compliance, Required
Direct and obvious relevance to regulatory compliance and/or research with human subjects, Preferred
Relevant program/project management, Preferred
Internal Number: R5813
About Spectrum Health West Michigan
At Spectrum Health, we strive to deliver personalized health made simple, affordable and exceptional. It’s a high bar. Yet with every day and every patient we meet, we are proving that extraordinary care is a goal worth achieving.
Spectrum Health is an integrated health system, with an award-winning health plan, teams of nationally recognized doctors, and providers and a network of hospitals and care facilities in Southwest and West Michigan.
By working together, we create better value and experiences for consumers. The result is a seamless, highly collaborative system of care that offers the best possible outcomes. It’s what we call integrated care, and you’ll find no better way to get healthy and stay healthy.
Join a team—31,000 strong—that cares for each other and is committed to improving health and inspiring hope. You would be joining a nationally known health system with an ambitious vision and we can’t do it alone. Our people are at the heart of what we do.
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