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 2022, the faculty and researchers in the Department of Pediatrics received over $52 million in research support, of which nearly $40 million was NIH-funded – this is the largest award in the department’s history. Of the department’s 200+ 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.
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.
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
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 of 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
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 $53,000 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 https://hr.wisc.edu/benefits/
Additional Information:
This position has been identified as a position that will be located in or regularly access UW Health locations. This position will need to adhere to UW Health policies and affiliated requirements. UW Health requires that anyone (all staff, faculty students, volunteers, and other affiliated individuals) working in or regularly accessing UW Health locations receive the COVID-19 primary vaccination series and first booster. This position will be required to adhere to that policy and if not in full compliance to have a plan for achieving full compliance within 40 days of the first day of employment. Additionally, you may be required to adhere to other vaccination requirements. Medical or religious accommodations will be considered.
The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment. University sponsorship is not available for this position.
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
kscholtens@pediatrics.wisc.edu
608-262-0006
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:
284619-AS