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Regulatory Coordinator
Job Group: Compliance, Legal, and Protection
Job Subgroup: Institutional Audit and Compliance
Salary Range (Annual):
20: $46,000-93,940 Employee Category: Academic Staff
Job Code: CP085
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Job Summary:
Provides regulatory support for research studies. Assists in all regulatory activities including reviewing documents, applications, and reports, and ensuring compliance with the internal and external regulatory framework. Ensures compliance with all regulations, laws, and research standards pertaining to research. Applies skills to a broad range of different types of studies, navigates resources, and identifies issues needing escalation. Performs quality checks and may train staff. Contributes to the development of new team and unit processes, procedures, tools, and training.
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Job Responsibilities:
- Develops, prepares, and submits protocol-specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee
- Develops clear and accurate informed consent documents
- Serves as regulatory contact person for research studies involving human subjects
- Maintains complete and accurate regulatory files and records
- Communicates directly with protocol sponsors related to regulatory documents and activities
- Provides guidance and direction to research teams regarding compliance with policies, procedures, and regulations
- Performs quality checks
- May lead and train other staff
- Contributes to the development of new team and unit processes, procedures, tools, and training
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Education:
Bachelor's Degree Preferred Minimum
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FLSA Status:
Exempt
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Institution Job:
No
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Required Supervisory Duty of at Least 2.0 Full-Time Equivalent (FTE) Employees:
No
- Employee Category:
Academic Staff
- Scaled Job:
No
- Salary Range (Annual):
20: $46,000-93,940
- Job Code:
CP085: Regulatory Coordinator
- Link directly to this job title: https://hr.wisc.edu/standard-job-descriptions/?q=CP085