University of Wisconsin - Madison

Position Vacancy Listing

PVL # 225328

Position Summary:
The Regulatory Coordinator will join the UW Carbone Cancer Center (UWCCC) Central Regulatory Team within the UWCCC Central Office, providing regulatory office support services to Investigators and Clinical Research Disease Oriented Teams. Under direction of a Regulatory Team Supervisor, the incumbent will join a complex, fast-paced, highly regulated, and continually changing oncology clinical research environment and provide support for clinical and translational oncology research studies. The incumbent will work independently, and as part of a group, using initiative and good judgement on multiple projects simultaneously, prioritizing deadlines and interdisciplinary collaboration. The incumbent must demonstrate excellent oral and written communication skills, attention to detail and strong organizational skills.

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:
Specific duties include:

1) 30% - Develop, prepare and submit complete and accurate protocol-specific application materials to all required regulatory bodies. This includes, but is not limited to, the UWCCC Protocol Review and Monitoring Committees (PRMC), UW-Madison and external IRBs, Institutional Biosafety Committee (IBC), UWHC Research Safety Committee, UWHC Clinical Research Unit (CRU), UW Radioactive Drug Research Committee (RDRC) and University Radiation Safety Committee (URSC).

2) 20% - Ensure adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office of Human Research Protections (OHRP), University of Wisconsin Hospital and Clinics (UWHC), University of Wisconsin, National Cancer Institute (NCI) and other pertinent regulatory agencies. Provide regulatory guidance and direction to research teams in order to ensure compliance with all applicable policies, procedures and regulations. The incumbent will be expected to apply knowledge of International Conference of Harmonization Good Clinical Practice (ICH GCP) guidelines to work performed.

3) 15% - Write clear and accurate informed consent documents and HIPAA (Health Insurance Portability and Accountability Act) Authorizations.

4) 15% - Serve as regulatory contact person for ongoing clinical research studies. For example, the incumbent will track all regulatory review submissions and approvals to ensure deadlines are met; communicate pertinent information to study teams and sponsors; and attend sponsor site visits as needed.

5) 15% - Create, maintain and update regulatory files during study start-up and throughout the duration of the project. Communicate with sponsors to ensure all regulatory components are complete and filed appropriately.

6) 5% - Complete required data elements in the UWCCC Clinical Trial Management System (OnCore) for all regulatory submissions according to database definitions and data entry requirements.

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