Manager Research Regulatory - Cancer Center

About the Role

The regulatory manager is responsible for leadership and overarching departmental expectations and practices for the regulatory team, which includes 2 regulatory supervisors and 17 Research Regulatory staff members. The goal is to monitor team performance measures, identify and respond to trends, recognize opportunities for improvement, and implement solutions related to team functions and regulatory compliance. Key areas of focus include activation and amendment timelines, process improvement, change management, work quality, and staff performance.

Responsibilities

• Serve as the functional manager representing the Regulatory Team at meetings with partner organizations and internal process discussions.
• Collaborate with principal investigators, sponsors, study team members, and representatives from other departments and institutions, maintaining open communication.
• Act as a resource for investigators and support staff on pre-trial and ongoing trial maintenance functions, including regulatory documents, safety committee reviews, IND applications, IRB applications, trial amendments, annual progress reports, and CT.gov applications.
• Advise study investigators and support staff on administrative and regulatory aspects of human subject research.
• Manage time, workload, and performance for the regulatory team, including recruitment, training, and performance evaluation.
• Collaborate with the Education/QA team on training materials and quality assurance activities.
• Maintain protocol activation timelines and track deadlines for program components using systems like OnCore, Florence, RightFax, and eBridge.
• Collect, analyze, and disseminate program data, reporting progress to stakeholders.
• Develop and implement departmental policies, procedures, and organizational tools to ensure compliance with institutional and regulatory standards.
• Act as a liaison between department leadership and research staff, and work with external agencies to advance research goals.
• Develop and monitor departmental research quality improvement (QI) activities and conduct quality control processes.
• Perform as a regulatory specialist/coordinator for select projects as needed.
• Coordinate notifications for annual regulatory education requirements and program outreach activities.

Qualifications

• Education: Bachelor’s degree (minimum); experience may substitute for education on an equivalent basis.
• Experience: 6 years of experience in research program coordination or regulatory; prior work with clinical research, regulatory, or patient care preferred.
• Certifications: CCRC or CCRP required; CITI training required within 90 days of hire.

Skills

• Knowledge of basic science, mathematics, documentation, and records management.
• Working knowledge of eBridge, electronic IRB, and Grants and Contracts functions.
• Excellent oral and written communication skills.
• Strong critical thinking, problem-solving, and attention to detail.
• Strong computer skills and data utilization.
• Leadership and staff management skills.

Physical Requirements

Work requires occasionally lifting moderate weight materials, standing, or walking continuously. Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.

Benefits

• Outstanding Healthcare Coverage (Health, Vision, Dental, Flexible Spending)
• 403B Retirement Package
• Competitive Vacation and Paid Holidays
• Tuition Reimbursement
• Paid Parental Leave
• Employee & Family Assistance Program (EFAP)
• Pet Insurance
• On-campus Fitness Facility with onsite classes
• Discounts on cell phone plans, fitness facilities, and local entertainment

About MCW

At MCW, all endeavors are driven by shared organizational values: Caring, Collaborative, Curiosity, Inclusive, Integrity, and Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives. Our mission is to improve health outcomes through education, research, and community engagement.