Clinical Trials Regulatory Coordinator Dept of Medicine

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Job Profile:

Job Summary:

The Department of Medicine (DOM) Office of Research Services (ORS) is seeking a Regulatory Coordinator to provide comprehensive support services to faculty conducting clinical research. This position will work closely with investigators research coordinators industry sponsors contract research organizations and others to coordinate the preparation of documents necessary to obtain and maintain protocol approval from various Institutional Review Boards (e.g. UW Health Sciences commercial VA) and research oversight bodies.

The DOM ORS supports clinical research professionals and participants in advancing medical discovery to improve health outcomes across Wisconsin and beyond. ORS provides expert guidance resources and infrastructure to facilitate high-quality clinical trials and foster collaboration among investigators industry partners and research teams.

The Regulatory Coordinator will be expected to serve in a variety of capacities including but not limited to preparation and submission of protocols and compliance documents tracking and meeting renewal deadlines collection and maintenance of research records and consent documentation review of study proposals to ensure compliance and training of new investigators and staff on regulatory requirements. They will report to the DOM Regulatory Manager.

• 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.

• Terminal 24 month appointment

• This position has the possibility to be extended or converted to an ongoing appointment based on need and/or funding.

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

• Ability to listen understand and communicate information and ideas effectively in writing over the phone or in person.

• Comfort in exercising independent discretion

• Ability to work well as part of a team

• Excellent organization and time management skills

• Attention to detail and ability to simultaneously manage many detailed projects and meet deadlines

Key Job Responsibilities:

• Develops prepares and submits protocol-specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee

• Develops prepares and submits regulatory application materials to other regulatory bodies such as the Food and Drug Administration (FDA)

• Contributes to the development of new team and unit processes procedures tools and training

• 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

• Serves as regulatory contact person for research studies involving human subjects

• Develops clear and accurate informed consent documents

Department:

School of Medicine and Public Health Department of Medicine Office of Research Services

Fueled by innovation yet grounded in kindness the Department of Medicineempowers leaders to transform medicine and improve lives everywhere. We are committed to professional fulfillment and health strive to ensure that everyone in our department understands the importance of social impact and belongingand is empowered to champion it in all they us and be a part of supporting our nationally recognized faculty innovative medical education programs and exceptional clinical care as we work towards our vision of healthy people and healthy communities!

Compensation:

The expected salary range for this position is $60000 up to $85000 for highly experienced candidates and actual pay within this range will depend 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 Faculty /Academic Staff Benefits Flyer 2026.

Required Qualifications:

• Minimum of 2 years experience in research compliance activities related to IRB submissions for clinical trial research.

• At least 2 years of experience in regulatory oversight activities and familiarity with university organizational policies and procedures.

Preferred Qualifications:

• Familiarity and/or experience with UW research infrastructure and platforms (e.g. Research and Sponsored Programs ARROW OnCore Florence)

• Knowledge or willingness to learn the following regulations and guidelines: University State FDA Good Clinical Practice (GCP) Guidelines Health Information and Accountability (HIPAA) Code of Federal Regulations and The Protection of Human Research Subjects

Education:

• Bachelors Degree preferred; focus in health administration biological sciences social sciences business or related field preferred

How to Apply:

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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 all required documents in that field either as a single combined file or as multiple files in the same upload area.

Upload required documents:

• Cover letter

• Resume

Your cover letter should address how your training and experience align 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. References will be requested from final candidates. All applicants will be notified once the search concludes and a candidate is selected

University sponsorship is not available for this position including transfers of sponsorship and TN 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 currently scheduled to endtwo years from date of hire and will require eligibility to work until that time.If you are selected for this position you must provide proof of work authorization and eligibility to work.

Contact Information:

Jenelle Grogan

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

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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 OpportunityEmployer.

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 backgroundsand 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 accommodationfor 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 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).

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