Regulatory Coordinator

Universities of Wisconsin•Madison, WI

19h•Remote

About The Position

The Department of Radiology at the University of Wisconsin–Madison School of Medicine and Public Health is seeking a detail-oriented and motivated Regulatory Coordinator to support a diverse portfolio of imaging-based research studies. This role provides regulatory support across all phases of research, including the preparation, drafting, review, and submission of regulatory documents, applications, and reports, while ensuring compliance with institutional, state, and federal requirements. The coordinator will apply regulatory knowledge across a broad range of study types, perform quality checks, and assist with audits and compliance reviews. This position also contributes to the development and improvement of team processes, procedures, tools, and training, and collaborates closely with investigators, study teams, and research staff to support the department’s mission of discovery, education, and excellence in research. This position offers a unique opportunity to support cutting-edge imaging research, including studies involving novel PET radiotracers, while gaining exposure to FDA regulatory submissions and maintenance, such as Drug Master Files (DMFs), Investigational New Drug (IND) applications, amendments, and annual reports. The Department of Radiology offers a dynamic, interdisciplinary environment that integrates advanced imaging technologies with leading research initiatives. Ideal candidates value collaboration, continuous improvement, and service excellence while supporting regulatory operations that enable high-quality, compliant research. It is anticipated that this position will be remote and requires work be performed at an offsite, non-campus work location. Must be willing to attend onsite meetings, training, and audits as requested by the department. Successful candidates who address the following Knowledge, Skills, and Abilities in their cover letter will be given first consideration; Strong organizational and time management skills with the ability to manage multiple priorities; Excellent attention to detail and accuracy in regulatory documentation; Effective written and verbal communication skills; Knowledge of human subjects’ protections and clinical research processes.

Requirements

At least one (1) year of experience in a research environment demonstrating familiarity with compliance requirements, research ethics, and research methodologies.

Nice To Haves

At least one (1) year of experience in an academic healthcare, clinical research, or regulated research setting.
Experience supporting regulatory submissions or maintaining regulatory documentation.
Experience preparing or supporting Institutional Review Board (IRB) submissions and regulatory documentation.
Familiarity with clinical research systems and tools such as Florence eBinders and OnCore.

Responsibilities

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
Coordinates and conducts independent monitoring reviews in accordance with the study monitoring plan. Schedules, coordinates, and prepares for external sponsor site visits.
Performs quality checks
Prepares and submits submissions to the FDA for INDs and DMFs (e.g. Initial submissions, annual reports, amendments, etc.)
Provides guidance and direction to research teams regarding compliance with policies, procedures, and regulations
Contributes to the development of new team and unit processes, procedures, tools, and training
Communicates directly with protocol sponsors related to regulatory documents and activities
May lead and train other staff
Maintains complete and accurate regulatory files and records