University of Wisconsin - Madison

Position Vacancy Listing

PVL # 234585

Position Summary:
The Regulatory Specialist provides investigator support services for clinical research in the Department of Surgery at the UW School of Medicine and Public Health. 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).

The School of Medicine and Public Health has a deep and profound commitment to diversity both as an end in itself but, also as a valuable means for eliminating health disparities. As such, we strongly encourage applications from candidates who foster and promote the values of diversity and inclusion.

Principal duties:
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:
20% 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 current issues in the ethical conduct of clinical research.
- Understanding and incorporating required elements and human subjects protection.
- Application of problem solving and communication skills to resolve ambiguities, eliminate deficiencies, and ensure clarity of protocols.

15% Communicate effectively with and provide guidance to faculty investigators, research coordinators, staff, HS-IRB staff, MR-IRB staff, and VA Research Office staff to ensure compliance with expectations, human subjects requirements, and institutional and regulatory requirements.

10% 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.

10% Maintain and monitor departmental review and approval process for IRB submissions and track associated costs.

10% Assist in clinical research training initiatives for the Department. Answer questions and problem solve for faculty investigators, research coordinators, and staff.

10% Maintain and monitor system and track all clinical research protocol submissions, modification notices, modifications, annual updates, and termination of studies. Ensure proactive renewal of protocol applications, timely submission of protocol amendments/modifications as necessary, and timely study closure.

10% Monitor all Delegation of Authority logs for each clinical trial and ensure completion of all protocol training and documentation per sponsor.

5% Submit serious adverse event reports, Data Safety Monitoring Board findings, Investigator Brochure updates, and protocol deviations as required. Develop, implement, maintain and train others on Standard Operating Procedures (SOPS) for clinical trials.

5% Develop patient oriented materials, such as study subject recruitment flyers, letters, Informed Consent documents, HIPAA Authorizations, and advertisements.

5% Other Duties:
-Contribute to the development of a comprehensive logistical plan and accurate budget for study protocols such that plans and budgets are congruent with the research application and consent forms.
-Identify research protocols or issues that would benefit from review by an outside expert and coordinate the process to meet these requirements.
-Assist investigators with federal applications such as Investigational New Drug, Investigational Device Exemption, and Certificates of Confidentiality.
-Participate in special projects assigned by the Director of Clinical Trials Research and the Chair of Research.
-Submit and maintain clinicaltrials.gov records.

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