Regulatory Specialist

University of Wisconsin Madison
$41,244 ANNUAL (12 months)
sick time
United States, Wisconsin, Madison
21 North Park Street (Show on map)
Jan 27, 2025
Job Summary: The Wisconsin Reading Center (WRC), seeks a collaborative individual to assist with the regulatory and quality assurance needs of clinical research studies. The WRC is a core lab within the Department of Ophthalmology. The incumbent will be responsible for ensuring clinical processes are followed in accordance with guidelines and regulations. Develops, performs, and assists in quality assurance activities. Responsibilities: Assists in all regulatory activities including reviewing documents, applications, and reports and ensuring compliance with internal and external regulatory framework. 30% Ensures compliance with all regulations and laws pertaining to unit's business 30% Compiles and maintains appropriate documents for regulatory submissions 20% Conducts research to support regulatory submissions 5% Prepares and submits documentation to regulatory agencies 15% 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 - Previous experience working with a centralized reading center for clinical trials. - Previous experience working on user acceptance testing and/or computer system qualification. - Previous experience working Flywheel software. Preferred - Great interpersonal skills and highly organized. - High level of attention to detail and computer skills. - Previous experience implementing regulatory requirements into business processes. Work Type: Part Time: 60% - 80% 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: Terminal, 11 month appointment. This position has the possibility to be extended or converted to an ongoing appointment based on need and/or funding Salary: Minimum $41,244 ANNUAL (12 months) Depending on 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. Benefits information can be found at (https://hr.wisc.edu/benefits/). 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. You will also be asked to provide contact information for three (3) references, including your current/most recent supervisor during the application process. References will not be contacted without prior notice. Contact: Beth Reuter ejreuter@wisc.edu 608-263-3680 Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information. Official Title: Regulatory Specialist(CP051) Department(s): A53-MEDICAL SCHOOL/OPHTHAL&VIS SCI/FPRC Employment Class: Academic Staff-Terminal Job Number: 310636-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. For more information regarding applicant and employee rights and to view federal and state required postings, click here 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: https://employeedisabilities.wisc.edu/disability-accommodation-information-for-applicants/ Employment may require a criminal background check. It may 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.