Regulatory Coordinator

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
• Prioritization 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 include:

• 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

The starting salary for the position is $60,000 annually; 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.

Required qualifications include a bachelor's degree. Preferred qualifications include experience with Institutional Review Board (IRB) submissions or equivalent types of submissions, experience with human subjects research, and experience with relevant software systems.

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. 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. 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 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 choose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your legal or waiver fees.

Hope Jende, hope.jende@wisc.edu, 608-262-0149

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

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.