Regulatory Coordinator

UW School of Medicine and Public Health; Madison (WI); On-site; USD 59,000 - 72,000; Full time

Job summary

UW School of Medicine and Public Health is seeking a Regulatory Coordinator in Madison to support imaging-based research studies. The role involves drafting, reviewing, and submitting regulatory documents while ensuring compliance with institutional and federal requirements.

The position offers remote work with on-site meetings as needed. A Bachelor's in health sciences or related field is preferred, and prior regulatory submission experience is valued.

Qualifications

• At least one year of experience in a research environment with compliance requirements, research ethics, and methodologies.
• Experience supporting regulatory submissions or maintaining regulatory documentation.
• Familiarity with clinical research systems such as Florence eBinders and OnCore.
• Bachelor's degree preferred; focus in health sciences or related field.

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

Skills

Organizational skills

Attention to detail

Regulatory documentation

Written communication

Verbal communication

Human subjects protections

Education

Bachelor's degree in health sciences or related field

Tools

Florence eBinders

OnCore

Job description

Current Employees

If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process.

Job Category

Academic Staff

Employment Type

Regular

Job Profile

Regulatory Coordinator

Job Summary

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.

ADDITIONAL JOB DETAILS

• 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.

Key Job 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

Department

School of Medicine and Public Health, Department of Radiology, Research Program - Regulatory.

Join UW Radiology and UW Health—A Legacy of Innovation

The University of Wisconsin Department of Radiology, in partnership with UW Health, has been at the forefront of clinical care, imaging research, and education for nearly a century. Since its inception on May 18, 1927—when Dr. Ernst Pohle was appointed as the first professor of Radiology—the department has grown to more than 160 faculty members across 14 specialized sections, serving as a key pillar of UW Health’s world‑class medical enterprise.

What Sets Us Apart

• Collaborative Excellence: Strong partnerships with UW Health, Medical Physics, and leading equipment vendors drive continuous advancements in imaging.
• Cutting-Edge Technology: We utilize state‑of‑the‑art imaging in CT, MR, PET/CT, PET/MR, angiography, ultrasound, PACS, and AI‑driven medical imaging.
• Robust Research Infrastructure: Dedicated support for grant writing, media specialists, research nurses, technologists, and data managers enhance investigative success.
• Premier Imaging Facilities: The WIMR Imaging Sciences Center offers 60,000 square feet of advanced imaging space, including MRI, PET/MRI, PET/CT, CT, ultrasound, angiography, cyclotron, radiopharmaceutical production and comprehensive small animal imaging technologies.

Together, UW Radiology and UW Health are committed to advancing human health through groundbreaking clinical care, pioneering research, and excellence in education. We foster a respectful, adaptive, and accountable environment—one that prioritizes innovation while serving the needs of all patients, including underserved populations.

Visit our official website to learn more about our work and opportunities.

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. For more information, refer to the campus benefits webpage and the SMPH Academic Staff Benefits Flyer

Required Qualifications

• 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.

University sponsorship is not available

University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. If you are selected for this position, you must provide proof of work authorization and eligibility to work.

The department will not be able to support a request for a J-1 waiver. If you chose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your legal or waiver fees.

Contact Information

Amanda Michalski, [e-mail]

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. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin‑Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.

Equal Opportunity Employer

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgrounds and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, visit the Human Resources Workplace Poster website.

To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you.

Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment.

The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).

The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on‑campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW‑Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.