Clinical Trials Regulatory Coordinator - Dept of Medicine
University of Wisconsin, Madison, WI, United States
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Job Category:
Academic Staff
Employment Type:
Terminal (Fixed Term)
Job Profile:
Regulatory Coordinator
Job Summary:
The Department of Medicine Office of Research Services is seeking a Regulatory Coordinator to provide comprehensive support services to faculty conducting clinical research. This position will work closely with investigators, research coordinators, industry sponsors, contract research organizations and others to coordinate the preparation of documents necessary to obtain and maintain protocol approval from various Institutional Review Boards (e.g., UW Health Sciences, commercial, VA) and research oversight bodies.
The DOM ORS supports clinical research professionals and participants in advancing medical discovery to improve health outcomes across Wisconsin and beyond. ORS provides expert guidance, resources, and infrastructure to facilitate high‑quality clinical trials and foster collaboration among investigators, industry partners, and research teams.
The Regulatory Coordinator will be expected to serve in a variety of capacities, including but not limited to preparation and submission of protocols and compliance documents, tracking and meeting renewal deadlines, collection and maintenance of research records and consent documentation, review of study proposals to ensure compliance, and training of new investigators and staff on regulatory requirements. They will report to the DOM Regulatory Manager.
Key Details:
May require some in‑person work at a designated campus work location; some work may be performed remotely.
Terminal 24‑month appointment.
Possibility for extension or conversion to ongoing appointment based on need and funding.
Key Job Responsibilities:
Develop clear and accurate informed consent documents.
Serve as regulatory contact person for research studies involving human subjects.
Maintain complete and accurate regulatory files and records.
Communicate directly with protocol sponsors related to regulatory documents and activities.
Provide guidance and direction to research teams regarding compliance with policies, procedures, and regulations.
Perform quality checks.
May lead and train other staff.
Contribute to the development of new team and unit processes, procedures, tools, and training.
Develop, prepare, and submit regulatory application materials to other regulatory bodies such as the Food and Drug Administration.
Develop, prepare, and submit protocol‑specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee.
Qualifications:
Minimum of 2 years’ experience in research compliance activities related to IRB submissions for clinical trial research.
At least 2 years of experience in regulatory oversight activities and familiarity with university organizational policies and procedures.
Preferred Qualifications:
Familiarity and/or experience with UW research infrastructure and platforms (e.g., Research and Sponsored Programs, ARROW, OnCore, Florence).
Knowledge or willingness to learn regulations and guidelines: University, State, FDA, ClinicalTrials.gov, Good Clinical Practice (GCP) Guidelines, Health Information and Accountability (HIPAA), Code of Federal Regulations, and The Protection of Human Research Subjects.
Education:
Bachelor’s Degree preferred; focus in health administration, biological sciences, social sciences, business or related field.
Department:
School of Medicine and Public Health, Department of Medicine, Office of Research Services
Compensation:
The expected salary range for this position is $60,000 up to $85,000 for highly experienced candidates, with actual pay within this range depending on experience and qualifications.
Employees in this position can expect benefits such as generous vacation, holidays, sick leave; competitive insurances and savings accounts; retirement benefits.
Institutional Statement on Diversity:
Diversity is a source of strength, creativity, and innovation for UW‑Madison. The university values the contributions of each person and respects the profound ways their identity, culture, background, experience, status, abilities, and opinion enhance the community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity.
The University of Wisconsin‑Madison is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies.
To request a disability or pregnancy‑related accommodation for any step in the hiring process, please contact the Divisional Disability Representative in your division.
Employment may require a criminal background check.
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Job Category:
Academic Staff
Employment Type:
Terminal (Fixed Term)
Job Profile:
Regulatory Coordinator
Job Summary:
The Department of Medicine Office of Research Services is seeking a Regulatory Coordinator to provide comprehensive support services to faculty conducting clinical research. This position will work closely with investigators, research coordinators, industry sponsors, contract research organizations and others to coordinate the preparation of documents necessary to obtain and maintain protocol approval from various Institutional Review Boards (e.g., UW Health Sciences, commercial, VA) and research oversight bodies.
The DOM ORS supports clinical research professionals and participants in advancing medical discovery to improve health outcomes across Wisconsin and beyond. ORS provides expert guidance, resources, and infrastructure to facilitate high‑quality clinical trials and foster collaboration among investigators, industry partners, and research teams.
The Regulatory Coordinator will be expected to serve in a variety of capacities, including but not limited to preparation and submission of protocols and compliance documents, tracking and meeting renewal deadlines, collection and maintenance of research records and consent documentation, review of study proposals to ensure compliance, and training of new investigators and staff on regulatory requirements. They will report to the DOM Regulatory Manager.
Key Details:
May require some in‑person work at a designated campus work location; some work may be performed remotely.
Terminal 24‑month appointment.
Possibility for extension or conversion to ongoing appointment based on need and funding.
Key Job Responsibilities:
Develop clear and accurate informed consent documents.
Serve as regulatory contact person for research studies involving human subjects.
Maintain complete and accurate regulatory files and records.
Communicate directly with protocol sponsors related to regulatory documents and activities.
Provide guidance and direction to research teams regarding compliance with policies, procedures, and regulations.
Perform quality checks.
May lead and train other staff.
Contribute to the development of new team and unit processes, procedures, tools, and training.
Develop, prepare, and submit regulatory application materials to other regulatory bodies such as the Food and Drug Administration.
Develop, prepare, and submit protocol‑specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee.
Qualifications:
Minimum of 2 years’ experience in research compliance activities related to IRB submissions for clinical trial research.
At least 2 years of experience in regulatory oversight activities and familiarity with university organizational policies and procedures.
Preferred Qualifications:
Familiarity and/or experience with UW research infrastructure and platforms (e.g., Research and Sponsored Programs, ARROW, OnCore, Florence).
Knowledge or willingness to learn regulations and guidelines: University, State, FDA, ClinicalTrials.gov, Good Clinical Practice (GCP) Guidelines, Health Information and Accountability (HIPAA), Code of Federal Regulations, and The Protection of Human Research Subjects.
Education:
Bachelor’s Degree preferred; focus in health administration, biological sciences, social sciences, business or related field.
Department:
School of Medicine and Public Health, Department of Medicine, Office of Research Services
Compensation:
The expected salary range for this position is $60,000 up to $85,000 for highly experienced candidates, with actual pay within this range depending on experience and qualifications.
Employees in this position can expect benefits such as generous vacation, holidays, sick leave; competitive insurances and savings accounts; retirement benefits.
Institutional Statement on Diversity:
Diversity is a source of strength, creativity, and innovation for UW‑Madison. The university values the contributions of each person and respects the profound ways their identity, culture, background, experience, status, abilities, and opinion enhance the community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity.
The University of Wisconsin‑Madison is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies.
To request a disability or pregnancy‑related accommodation for any step in the hiring process, please contact the Divisional Disability Representative in your division.
Employment may require a criminal background check.
#J-18808-Ljbffr