Research Regulatory Supervisor Remote

Research Regulatory Supervisor

Every great life-changing discovery begins the same way-with new knowledge. It can change everything, from a single life to the future of entire communities. That's why academic medicine, and the continuous pursuit of knowledge, is at the center of everything we do at the Medical College of Wisconsin (MCW). In the role of a Research Regulatory Supervisor you will be working in our Center for Cancer Discovery. Purpose Supervise regulatory personnel, and responsible for overseeing daily operations, quality and timeliness of regulatory activities. Primary Functions :

• Supervise staff including overseeing daily operations of the regulatory team to ensure compliance with state and federal regulations.
• Develop, improve, and apply standard education, processes, and procedures requiring specialized experience to assure timely, quality, and compliant work in conjunction with Regulatory CRQA Specialist and Regulatory Manager.
• Ensure creation and maintenance of accurate, timely and compliant regulatory records and data, providing information for evaluation and specific recommendations for improvement.
• Operationalize and implement proposed solutions or process improvements related to identified problems or obstacles in the system / procedures related to implementation of the research protocols.
• Draft, submit, and advise on regulatory submissions including but not limited to protocols, protocol summaries, amendments, protocol deviations, serious adverse and other reportable events, continuing progress reports, and consent-to-treat documents without need for supervision. Following IRB and IBC guidelines, prepare and / or provide guidance to Regulatory Specialists for drafting / modifying IRB and IBC documents or other safety committee and regulatory documents as required by research program activities.
• Keep abreast of changing regulations and regulatory techniques and methodologies that might facilitate designated research projects.
• Demonstrate processes and procedures and provide individualized instruction for regulatory staff and other partners as required. Perform as a regulatory specialist / coordinator for select projects as needed. Maintain protocol activation timeline including tracking deadlines for program components. Utilize MCW's Clinical Trial Management System (CTMS) OnCore and other system to assist with meeting regulatory requirements and tracking activities. Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders Manage other data systems, such as Florence, RightFax, and eBridge which support research.

The Medical College of Wisconsin is an affirmative action / equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, veteran status, disability or sexual orientation.