Supervisor Research Regulatory – Cancer Center

This is a fully remote position, open to applicants in Alabama, +13 more locations.

📋 Description

• Oversee regulatory personnel and manage daily operations, ensuring quality and timely execution of regulatory activities.

• Ensure the regulatory team adheres to both state and federal regulations.

• Collaborate with the Regulatory CRQA Specialist and Regulatory Manager to develop, enhance, and implement educational programs, processes, and procedures.

• Guarantee the accuracy, timeliness, and compliance of regulatory records and data.

• Implement enhancements in processes related to research protocol systems and procedures.

• Prepare, submit, and provide guidance on regulatory submissions, including protocols, amendments, deviations, reportable events, progress reports, and consent-to-treat documents.

• Prepare or assist staff with IRB, IBC, safety committee, and other regulatory documentation.

• Stay informed about evolving regulations, techniques, and methodologies.

• Demonstrate processes and offer tailored instruction to regulatory staff and collaborators.

• Perform regulatory specialist/coordinator responsibilities for selected projects as necessary.

• Maintain timelines for protocol activation and monitor program deadlines.

• Utilize MCW’s CTMS OnCore and other systems to fulfill regulatory requirements and track activities.

• Gather, analyze, and disseminate program data; provide progress reports to stakeholders.

• Manage systems such as Florence, RightFax, eBridge, and other data systems that support research.

• Communicate with local and central IRBs.

• Collaborate with various teams and departments to further research objectives.

⛳️ Requirements

• A Bachelor’s degree is mandatory.

• A minimum of 5 years in compliance or healthcare is required.

• CCRC or CCRP certification is required.

• CITI training must be completed within 90 days of hire.

• Proficiency in biology, chemistry, mathematics, documentation, regulatory compliance, interpreting regulations, and records management.

• Strong oral and written communication abilities.

• Skills in critical thinking, problem-solving, and meticulous attention to detail.

• Experience in data utilization and resource management.

• Equivalent experience may be accepted in lieu of educational qualifications.

🏝️ Benefits

• Exceptional Healthcare Coverage, including Health, Vision, and Dental.

• Options for Flexible Spending.

• 403B Retirement Package.

• Competitive vacation and paid holidays offered.

• Tuition Reimbursement available.

• Paid Parental Leave.

• Employee & Family Assistance Program (EFAP).

• Pet Insurance offered.

• On-campus fitness facility with onsite classes available.

• Discounted rates on select cell phone plans, local fitness facilities, and Milwaukee recreation and entertainment.