Manager, Research Regulatory – Cancer Center

MCW

. Lead the regulatory team consisting of 2 regulatory supervisors and 17 Research Regulatory staff members .

Posted 9/22/2026full-timeMilwaukee • Wisconsin • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance, team leadership, and research program coordination, with a strong focus on quality improvement and data management. Proficient in utilizing regulatory tracking systems and collaborating with diverse stakeholders to ensure adherence to protocols and enhance research outcomes.

Highest-signal resume keywords

Regulatory Compliance ManagementTeam Leadership and Staff OversightOnCore CTMS UtilizationCCRC or CCRP CertificationCITI Training

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Research Program CoordinationRegulatory Specialist DutiesData Analysis and ReportingQuality Improvement ToolsDocumentation and Records Management

Soft Skills

Excellent Oral and Written CommunicationCritical ThinkingProblem SolvingAttention to DetailResource Management

Tools & Technologies

OnCore CTMSE-BridgeRightFaxFlorenceElectronic IRB

Certifications & Qualifications

CCRCCCRPCITI Training

Industry Keywords

Human Subject ResearchRegulatory Team LeadershipClinical ResearchProtocol ActivationQuality Control Processes

About the role

Key responsibilities & impact

Lead the regulatory team consisting of 2 regulatory supervisors and 17 Research Regulatory staff members
Monitor team performance measures, identify and report trends, recognize improvement opportunities, and implement solutions related to team functions and regulatory compliance
Represent the Regulatory Team at partner-organization meetings and internal process discussions
Collaborate with principal investigators, sponsors, study team members, other departments, and institutions
Advise investigators and support staff on pre-trial and ongoing trial maintenance and regulatory aspects of human subject research
Manage team time, workload, and performance
Recruit and train clinical research staff; establish expectations; assess workload, timelines, competencies, and performance
Collaborate with Education/QA on training materials and quality assurance activities
Maintain protocol activation timelines and track program-component deadlines
Use OnCore CTMS and other systems to track regulatory activities and requirements
Collect, analyze, and disseminate program data; report progress to stakeholders
Manage Florence, RightFax, and eBridge systems supporting research activities
Correspond with local and central IRBs
Develop and implement departmental policies, procedures, and organizational tools for compliance
Identify system and procedural obstacles related to research protocol implementation
Liaise between department leadership and research staff, other departments, external agencies, and community organizations
Develop, implement, and monitor research quality-improvement activities and quality-control processes
Develop clinical data review plans and check specifications
Use quality-improvement tools and statistical process control to improve systems and processes
Perform regulatory specialist/coordinator duties for select projects
Coordinate annual regulatory education notifications
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s degree required
Appropriate experience may be substituted for education on an equivalent basis
6 years of experience in research program coordination or regulatory required
CCRC or CCRP required
CITI training required within 90 days of hire
Knowledge of basic science and mathematics, documentation, and records management
Working knowledge of e-Bridge, electronic IRB, and Grants and Contracts functions
Excellent oral and written communication skills
Strong critical thinking, problem solving, and attentiveness to detail
Strong computer skills
Sufficient knowledge of the program study area
Strong leadership and staff oversight and management skills
Data utilization, complex problem solving, critical thinking, resource management, and writing skills
Ability to meet physical, sensory, and work-environment requirements

Benefits

Comp & perks

Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental
Flexible Spending options
403B Retirement Package
Competitive Vacation and Paid Holidays offered
Tuition Reimbursement
Paid Parental Leave
Employee & Family Assistance Program (EFAP)
Pet Insurance
On campus Fitness Facility, offering onsite classes
Discounted rates on select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment