Regulatory Coordinator

Universities of Wisconsin•Madison, WI

2d•Hybrid

About The Position

The University of Wisconsin Department of Pediatrics is seeking a Regulatory Coordinator to provide comprehensive regulatory support for research studies. This role involves assisting with all regulatory activities, including the review of documents, applications, agreements, and reports, to ensure adherence to internal and external regulatory frameworks. The coordinator will be responsible for ensuring compliance with all regulations, laws, and standards pertinent to research. They will apply their skills across a variety of study types, utilize available resources, and identify issues that require escalation. Additionally, the position includes performing quality checks and potentially training staff. The role also contributes to the development of new team and unit processes, procedures, tools, and training. This position offers a valuable opportunity to gain exposure to diverse research studies within the Department of Pediatrics and to collaborate closely with dedicated clinician researchers in a mission-driven environment focused on serving children and families.

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
Continuous eligibility to work in the United States

Nice To Haves

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

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