Regulatory Coordinator

University of Wisconsin Madison•Madison, WI

12d•Hybrid

About The Position

The University of Wisconsin Department of Pediatrics is looking for a Regulatory Coordinator to provide regulatory support for research studies. The individual in this position will assist in all regulatory activities including reviewing documents, applications, agreements, and reports, and ensuring compliance with the internal and external regulatory frameworks. They will ensure compliance with all regulations, laws, and standards pertaining to research. They will also apply skills to a broad range of different types of studies, navigate resources, and identify issues needing escalation. They will perform quality checks and may train staff. Additionally, they will contribute to the development of new team and unit processes, procedures, tools, and training. This position is an excellent opportunity to learn about a wide variety of research studies across the Department of Pediatrics. The person who fulfills this role will have the opportunity to work closely with the department's talented and dedicated clinician researchers, working together to serve children and families in a mission-driven department. This position is full or part-time, 80%-100% This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.

Requirements

Effective oral and written communication skills
Independent problem solving and analytical skills
Attention to detail and organization
Prioritizations skills, including the ability to manage multiple projects
In-depth understanding of and/or willing and able to learn about clinical research principles and specific study and institutional guidelines
Ability to effectively support investigators and study teams with a service-oriented approach
Bachelor’s Degree preferred
Experience with Institutional Review Board (IRB) submissions or equivalent types of submissions
Experience with human subjects research
Experience with relevant software systems, such as or equivalent to: REDCap, ARROW, other electronic IRB systems, OnCore, HealthLink, Microsoft Office Suite, Adobe Acrobat, and file-sharing systems such as Google Drive or Box
Continuous work eligibility in the United States

Responsibilities

May lead and train other staff
Performs quality checks
Provides guidance and direction to research teams regarding compliance with policies, procedures, and regulations
Communicates directly with protocol sponsors related to regulatory documents and activities
Maintains complete and accurate regulatory files and records
Contributes to the development of new team and unit processes, procedures, tools, and training
Serves as regulatory contact person for research studies involving human subjects
Develops clear and accurate informed consent documents
Develops, prepares, and submits protocol-specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee