[Hiring] Regulatory Coordinator @Universities of Wisconsin

Role Description

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:

• Preparation, drafting, review, and submission of regulatory documents, applications, and reports
• Ensuring compliance with institutional, state, and federal requirements
• Applying regulatory knowledge across a broad range of study types
• Performing quality checks and assisting with audits and compliance reviews
• Contributing to the development and improvement of team processes, procedures, tools, and training
• Collaborating closely with investigators, study teams, and research staff

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

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.

Qualifications

• 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

Preferred Qualifications

• 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

Education

• Bachelors Preferred; focus in health sciences or a related field

Compensation

The starting salary for the position is $65,000; but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as:

• Generous vacation, holidays, and sick leave
• Competitive insurances and savings accounts
• Retirement benefits

How to Apply

For the best experience completing your application, we recommend using Chrome or Firefox as your web browser. To apply for this position, select either “I am a current employee” or “I am not a current employee” under Apply Now. You will then be prompted to upload your application materials.

Important: The application has only one attachment field. Upload the following documents in that field, either as a single combined file or as multiple files in the same upload area:

• Cover letter
• Resume

Your cover letter should address how your training and experience aligns with the required and preferred qualifications listed above. Application reviewers will rely on these written materials to determine which applicants move forward in the process.

Contact Information

Amanda Michalski, [email protected]

Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Institutional Statement on Diversity

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community.