Regulatory Coordinator

Current Employees:
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Academic Staff

Regular

Regulatory Coordinator

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

• 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

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://(Use the "Apply for this Job" box below)..

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…