Senior Clinical Trials Regulatory Lead

The Medical College of Wisconsin, Inc.; Wauwatosa (WI); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Health coverage

Tuition reimbursement

Paid parental leave

Vacation and holidays

Job summary

The Medical College of Wisconsin seeks a Regulatory Program Leader to coordinate day-to-day clinical research regulatory activities. You will mentor Regulatory Specialists, prepare submissions, and ensure compliance with federal/state laws and institutional SOPs.

You will act as a liaison between sponsors, investigators, study teams, and review committees, guiding startup, ongoing oversight, and regulatory education across the Cancer Center CTO programs.

Qualifications

• Bachelor’s degree required.
• Minimum 4 years in compliance or healthcare field.
• CITI certification required within 30 days of hire.
• SoCRA and/or ACRP Certification preferred within 6 months.
• Experience in clinical research regulatory affairs preferred.

Responsibilities

• Draft and submit protocols, amendments, deviations, SAE reports and continuing progress reports with minimal supervision.
• Prepare IRB documents and provide guidance for drafting/modifying IRB submissions as needed.
• Manage regulatory activities in MCW/CTMS OnCore to meet requirements and track progress.
• Coordinate submissions for IND/IDE and maintain regulatory files with regular monitoring.
• Lead startup activities for studies and submissions to SRC, DSMB, IBC, Radiation Safety, MRI and ClinicalTrials.gov.
• Advise researchers and study team members on regulatory needs and annual education requirements.
• Collaborate with investigators on development of program materials and reports.
• Identify bottlenecks and propose process improvements; supervise/mentor Regulatory Specialists.

Skills

Regulatory compliance

Oral and written communication

Critical thinking

Attention to detail

Problem solving

Education

Bachelor's degree

Tools

OnCore CTMS

IRB system

Job description

The Medical College of Wisconsin seeks a Regulatory Program Leader to coordinate day-to-day clinical research regulatory activities. You will mentor Regulatory Specialists, prepare submissions, and ensure compliance with federal/state laws and institutional SOPs.

You will act as a liaison between sponsors, investigators, study teams, and review committees, guiding startup, ongoing oversight, and regulatory education across the Cancer Center CTO programs.