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, and reports, and ensuring compliance with the internal and external regulatory framework. They will ensure compliance with all regulations, laws, and research standards pertaining to research. They will also apply skills to a broad range of different types of studies, navigates resources, and identifies 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, ranging from healthcare records reviews to neuroimaging studies to genetics research to national registries to drug trials. The person who fulfills this role will have the opportunity to work closely with the department's talented and dedicated clinician researchers, collaborating to serve children and families. The Department of Pediatrics' leadership, faculty, and staff value and prioritize inclusion, diversity, equity, access, and anti- racism. As such, the person in this role will support investigators with incorporating research strategies and methods that enhance these values in all aspects of study design and implementation. This position is an opportunity to join a growing department with a vibrant research program. Over the last decade, the University of Wisconsin Department of Pediatrics has undergone an impressive period of expansion and prosperity within all of its missions (education, research, clinical, outreach). In fiscal year 2023, the faculty and researchers in the Department of Pediatrics received over $55 million in research support, of which nearly $37 million was NIH-funded - this is the largest total award amount in the department's history. Of the department's 200+ current faculty members, approximately 1/3 serve as principal investigator on over 170 funded research projects spanning the department's 16 specialties. As such, there are ample opportunities for gaining new knowledge and experiences in a collaborative environment.

Responsibilities:

Provides regulatory support for research studies. Assists in all regulatory activities including reviewing documents, applications, and reports, and ensuring compliance with the internal and external regulatory framework. Ensures compliance with all regulations, laws, and research standards pertaining to research. Applies skills to a broad range of different types of studies, navigates resources, and identifies issues needing escalation. Performs quality checks and may train staff. Contributes to the development of new team and unit processes, procedures, tools, and training.

• 25% Develops, prepares, and submits protocol-specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee
• 5% Develops clear and accurate informed consent documents
• 15% Serves as regulatory contact person for research studies involving human subjects
• 15% Maintains complete and accurate regulatory files and records
• 5% Communicates directly with protocol sponsors related to regulatory documents and activities
• 20% Provides guidance and direction to research teams regarding compliance with policies, procedures, and regulations
• 5% Performs quality checks
• 5% May lead and train other staff
• 5% Contributes to the development of new team and unit processes, procedures, tools, and training

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. For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Education:

Preferred
Bachelor's Degree

Qualifications:

Required Qualifications:
- Effective oral and written communication skills, independent problem solving and analytical skills, attention to detail and organization Preferred Qualifications:
- Experience with Institutional Review Board (IRB) submissions or equivalent types of submissions
- Experience with or interest in 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 Additional Knowledge, Skills & Abilities:
- Excellent organizational and prioritizations skills, including the ability to manage multiple projects
- Knowledge and commitment to advance inclusion, diversity, equity, access, and anti-racism in all aspects of the department's research endeavors
- 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

Work Type:

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.

Appointment Type, Duration:

Ongoing/Renewable

Salary:

Minimum $55,000 ANNUAL (12 months)
Depending on Qualifications
Actual pay will depend on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and paid time off; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at

Additional Information:

University sponsorship is not available for this position. The selected applicant will be responsible for ensuring their continuous eligibility for employment in the United States on or before the effective date of the appointment. UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1-OPT STEM Extension participants.

How to Apply:

To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience as it relates to this role.

Contact:

Kelsey Scholtens


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

Official Title:

Regulatory Coordinator(CP085)

Department(s):

A53-MEDICAL SCHOOL/PEDIATRICS/PEDIATRICS

Employment Class:

Academic Staff-Renewable

Job Number:

296292-AS

The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, 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 through diversity and encourage all qualified individuals to apply. If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: Employment will require a criminal background check. It will also require you and your references to answer questions regarding 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 .

About University of Wisconsin Madison

The University of Wisconsin–Madison has been a catalyst for the extraordinary since its founding in 1848. Our students, staff, and faculty partake in world-class education and conduct prolific research that solves real-world problems. Our guiding principle is the Wisconsin Idea, a commitment to outreach that creates a better future for our state, our nation, and the world. We value the contributions of each person and recognize that diversity is a source of strength, creativity, and innovation.

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