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Working title:

Regulatory Specialist

Official title:

SR ADMIN PRGM SPEC

Degree and area of specialization:

Bachelor’s degree required, preferably in health care, biological sciences, social sciences, English, journalism, legal studies, communications, or related field.

Minimum number of years and type of relevant work experience:

Two to three years of relevant experience is preferred. Five to seven years of experience working with an IRB preferred. Experience working in human subjects research, grant writing, scientific writing, health care, or academic setting preferred. A minimum of 7 years of experience is required for appointment at the senior level. Prefix assignment determined by years of relevant work experience.

Principal duties:

This position provides comprehensive investigator support services for clinical research in the Department of Surgery (DOS) at the UW School of Medicine and Public Health (SMPH). In order to carry out these activities, the incumbent will work closely with both the Health Sciences Institutional Review board (HS-IRB), the Health Sciences Minimal Risk Institutional Review Board (MR-IRB), Western IRB (WIRB), UW Carbone Cancer Center and the Research and Development Committee of the William S. Middleton Veterans Hospital (VA Research Committee). This position reports to the Director of Clinical Research.

This position is responsible for distilling complex scientific protocols into clear, concise, and accurate clinical research applications, consent forms, and correspondence. Most critical is the ability to manage many detailed projects simultaneously, completing projects in a timely manner and meeting strict deadlines required by review committees, boards, as well as, by investigators and sponsors of clinical research.

SPECIFIC DUTIES:
1. Maintain and monitor standardized mechanism for IRB submissions that will:
Provide advice for department faculty; minimize faculty effort; provide training opportunities; and incorporate administrative preparation and review of protocols, applications, amendments, changes to protocols, one-time use requests, and adverse events.

2. Maintain and monitor a departmental review and approval process for IRB submissions and track associated costs.

3. Submit and maintain clinicaltrials.gov records.

4. Develop and prepare clinical research protocols, applications, amendments, changes to protocols, one-time use requests, and adverse events for submission to the HS-IRB, MR-IRB, WIRB and the VA Research Committee which involves:
- Understanding and interpreting complex research protocols.
- Understanding and applying appropriate, laws, rules, and regulations (including university, state, and federal).
- Understanding and applying curr

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