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Regulatory Coordinator

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🔥 0 minutes ago

🧀 Wisconsin – Remote

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đź’µ $65k / year

⏰ Full Time

🟢 Junior

đźš” Compliance

🚫👨‍🎓 No degree required

đź‘» Ghost score 0%

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Logo of University of Wisconsin-Madison

University of Wisconsin-Madison

10,000+ employees

📚 Education

🏛️ Government

Education • Government

University of Wisconsin-Madison is a public research university and flagship campus of the University of Wisconsin System located in Madison, WI. It is one of the largest research institutions in the United States, investing more than $1 billion annually in research across the humanities, sciences, and applied fields, and emphasizes public service through the long-standing “Wisconsin Idea. ” The university offers undergraduate and graduate programs, community outreach, and extensive campus resources and athletics, while promoting diversity, inclusive excellence, and community engagement.

đź“‹ Description

• Serve as regulatory contact person for research studies involving human subjects • Develop clear and accurate informed consent documents • Develop, prepare, and submit protocol-specific application materials to the IRB, scientific review committee, and other regulatory bodies • Coordinate and conduct independent monitoring reviews according to study monitoring plans • Schedule, coordinate, and prepare for external sponsor site visits • Perform quality checks • Prepare and submit FDA submissions for INDs and DMFs, including initial submissions, annual reports, and amendments • Guide research teams regarding compliance with policies, procedures, and regulations • Contribute to new team and unit processes, procedures, tools, and training • Communicate directly with protocol sponsors regarding regulatory documents and activities • May lead and train other staff • Maintain complete and accurate regulatory files and records

🎯 Requirements

• At least one (1) year of experience in a research environment demonstrating familiarity with compliance requirements, research ethics, and research methodologies • Must be willing to attend onsite meetings, training, and audits as requested by the department • Must continuously maintain eligibility to work in the United States without employer sponsorship • Must provide proof of work authorization and eligibility to work • Cover letter and resume required • Employment may require a criminal background check • References will be requested from final candidates

🏖️ Benefits

• Generous vacation, holidays, and sick leave • Competitive insurances and savings accounts • Retirement benefits

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