Clinical Trials Regulatory Coordinator - Dept of Medicine

Universities of Wisconsin • Madison, WI

13d • $60,000 - $85,000 • Hybrid

About The Position

The Department of Medicine (DOM) Office of Research Services (ORS) 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. 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. Terminal, 24 month appointment This position has the possibility to be extended or converted to an ongoing appointment based on need and/or funding. Candidates who demonstrate the following knowledge, skills, and abilities will be given first consideration: Ability to listen, understand and communicate information and ideas effectively in writing, over the phone or in person. Comfort in exercising independent discretion Ability to work well as part of a team Excellent organization and time management skills Attention to detail and ability to simultaneously manage many detailed projects and meet deadlines

Requirements

• 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.

Nice To Haves

• Familiarity and/or experience with UW research infrastructure and platforms (e.g., Research and Sponsored Programs, ARROW, OnCore, Florence)
• Knowledge or willingness to learn the following 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
• Bachelor’s Degree preferred; focus in health administration, biological sciences, social sciences, business or related field preferred

Responsibilities

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

Benefits

• Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level