| Job Summary: | The University of Wisconsin Department of Pediatrics is looking for a Regulatory Coordinator to provide regulatory support services to its investigators and Pediatric Clinical Research Coordination team. This individual will assist with all regulatory activities, including creating and reviewing documents, applications, and reports, and ensuring compliance with the internal and external regulatory framework; ensuring compliance with all regulations, laws, and research standards pertaining to research; applying skills to a broad range of different types of studies; navigating resources and identifying issues needing escalation; supporting investigators with protocol development and collaborating with study teams to develop study processes and procedures; assisting with the development of REDCap projects/ performing compliance and quality checks and potentially training staff; and contributing 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. SMPH is committed to being a diverse, equitable, inclusive and anti-racist workplace and is an Equal Employment Opportunity, Affirmative Action employer. Applications from Black, Indigenous and People of Color (BIPOC) individuals, LGBTQ+ and non-binary identities, women, persons with disabilities, military service members and veterans are strongly encouraged.
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 2021, the faculty and researchers in the Department of Pediatrics received over $51 million in research support, of which nearly $41 million was NIH-funded - this is the largest award in the department's history. Of the department's 190+ current faculty members, nearly 1/3 have principal investigator (PI) status on a funded research-project. Department researchers are currently PIs of over 600 IRB-approved studies, spanning its 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
- 10% Develops clear and accurate informed consent documents
- 15% Serves as regulatory contact person for research studies involving human subjects
- 5% 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
- 10% Contributes to the development of new team and unit processes, procedures, tools, and training
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| 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: | Preferred Qualifications:
- Experience with Institutional Review Board (IRB) submissions
- Experience with human subjects research
- Experience with relevant software systems such as 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:
- Effective oral and written communication skills, independent problem solving and analytical skills, and attention to detail
- Excellent organizational and prioritizations skills
- Knowledge and commitment to advance inclusion, diversity, equity, access, and anti-racism in all aspects o the department's research endeavors
- In-depth understanding of research clinical principles and study guidelines
- Ability to manage multiple projects
- Ability to effectively support investigators and study teams with a service-oriented approach |
| COVID-19 Considerations: | UW-Madison continues to follow necessary health and safety protocols to protect our campus from COVID-19. All employees remain subject to the COVID-19 Workplace Safety Policy: https://policy.wisc.edu/library/UW-5086. Please visit https://covidresponse.wisc.edu for the most up-to-date information. |
| 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 $50,000 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. |
| How to Apply: | To apply for this position, please click on the "Apply Now" button. You will be asked to upload a resume and cover letter as a part of the application process. Please ensure that the resume and cover letter address how you meet the minimum/preferred qualifications for the position. You will also be asked to provide three professional/supervisor references during the application process. References will not be contacted without prior notice. |
| Contact: | Ashley Yandre
ashley.yandre@pediatrics.wisc.edu
608-265-3961
Relay Access (WTRS): 7-1-1 (out-of-state: TTY: 800.947.3529, STS: 800.833.7637) and above Phone number (See RELAY_SERVICE for further information. ) |
