Regulatory Coordinator

University of Wisconsin-Madison

Regulatory Coordinator supporting FDA, IRB, and human-subjects compliance for UW–Madison’s imaging research studies. Maintaining submissions, monitoring reviews, and regulatory records.

Posted 8/25/2026full-timeRemote • Wisconsin • 🇺🇸 United StatesJunior💰 $65,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance and research methodologies, with a strong focus on developing informed consent documents and preparing submissions for regulatory bodies. Capable of coordinating monitoring reviews and guiding research teams in adherence to policies and procedures.

Highest-signal resume keywords

Regulatory ComplianceInformed Consent DevelopmentFDA SubmissionsResearch MethodologiesMonitoring Reviews

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ContactProtocol-Specific Application MaterialsQuality ChecksIND SubmissionsDMF Submissions

Soft Skills

CommunicationTeam LeadershipTraining

Industry Keywords

Human Subjects ResearchIRBResearch EthicsCompliance RequirementsResearch Procedures

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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