Regulatory Program Lead – Cancer Center Trials

Medical College of Wisconsin; Wisconsin; On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Health insurance

403B Retirement Package

Competitive Vacation and Paid Holidays

Tuition Reimbursement

Paid Parental Leave

EFAP

Pet Insurance

Job summary

Medical College of Wisconsin in Wisconsin is seeking a Regulatory Manager to lead the Regulatory Team, overseeing 2 supervisors and 17 staff, ensuring compliance and timely execution of trial activations and amendments.

You will collaborate with principal investigators, sponsors, and other departments, develop policies, mentor staff, and drive quality improvement across the regulatory program.

Qualifications

• Bachelor's degree and 6 years of relevant experience in research program coordination or regulatory.
• CCRC or CCRP certification required; CITI training within 90 days of hire.
• Experience with clinical research regulatory processes and QA activities.

Responsibilities

• Lead regulatory team, represent the Regulatory Team at meetings with partner organizations and internal discussions.
• Advise investigators on administrative and regulatory aspects of human subjects research.
• Oversee time, workload, and performance management for the regulatory staff.
• Recruit, train, and mentor staff; implement standardized expectations and quality assurance.
• Maintain protocol activation timelines and track regulatory requirements using CTMS OnCore.
• Coordinate education and outreach activities; communicate with IRBs and research sites.
• Develop and enforce departmental policies to ensure compliance with SOPs and regulations.

Skills

Regulatory leadership

Team management

Clinical trials knowledge

Regulatory documentation

Education

Bachelor's degree

Tools

CTMS OnCore

eBridge

Florence

RightFax

Job description

Medical College of Wisconsin in Wisconsin is seeking a Regulatory Manager to lead the Regulatory Team, overseeing 2 supervisors and 17 staff, ensuring compliance and timely execution of trial activations and amendments.

You will collaborate with principal investigators, sponsors, and other departments, develop policies, mentor staff, and drive quality improvement across the regulatory program.