Regulatory Coordinator

UW School of Medicine and Public Health; Madison (WI); Hybrid; USD 54,000 - 66,000; Full time

Job summary

The University of Wisconsin School of Medicine and Public Health, Department of Pediatrics, seeks a Regulatory Coordinator to provide regulatory support for diverse research studies. You will review documents, applications, agreements, and reports, ensuring compliance with internal and external regulatory frameworks.

You will apply clinical research principles and may train staff across teams. The role offers opportunity to work with clinician researchers, contribute to new processes, and

Qualifications

• > Experience with IRB submissions or equivalent types of submissions.
• > Experience with human subjects research.
• > Experience with software systems such as REDCap, ARROW, OnCore, HealthLink, MS Office, Adobe Acrobat, Google Drive/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 IRB and scientific review committee

Skills

Communication

Problem solving

Prioritization

Clinical research

Education

Bachelor’s Degree

Tools

REDCap

ARROW

OnCore

HealthLink

MS Office

Adobe Acrobat

Google Drive

Box

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 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.

Candidates who demonstrate the following knowledge, skills, and abilities will be given first consideration.

• 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

Key Job 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

Department

School of Medicine and Public Health, Department of Pediatrics, Regulatory Support

The Department of Pediatrics at the University of Wisconsin School of Medicine and Public Health is a vibrant academic department comprising more than 230 faculty members in 16 subspecialty divisions. The department promotes and enhances the health of children through outstanding clinical care, exemplary education of pediatric trainees, performance of cutting-edge research, and vigorous advocacy. Our faculty and research staff enjoy a robust infrastructure of services as well as the opportunity to contribute to our world-class research portfolio – since 2015 the department has ranked among the Top 20 pediatrics departments receiving NIH funding, according to Blue Ridge Institute for Medical Research.

To provide remarkable health care for everyone in our community, we are committed to fostering a diverse, equitable, and inclusive environment in all aspects of our work. To learn more about the department's work and accomplishments, please visit: https://www.pediatrics.wisc.edu/.

Compensation

The starting salary for the position is $60,000 annually; but is negotiable based on experience and qualifications.

• generous vacation, holidays, and sick leave
• competitive insurances and savings accounts
• retirement benefits

• SMPH Faculty /Academic Staff Benefits Flyer 2026

Required Qualifications

Preferred Qualifications

• 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

Education

Bachelor’s Degree preferred

Contact Information

Hope Jende, [e-mail], 608-262-0149

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.

The University of Wisconsin-Madison is an 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.