IRB & Research Regulatory Specialist

The Medical College of Wisconsin, Inc.; Wisconsin; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Paid Holidays

On-campus Fitness Center

Job summary

The Research Regulatory Specialist at MCW coordinates and prepares IRB applications, amendments, and continuing reviews for human subjects research to ensure compliance with federal, state, and institutional SOPs. You will act as the regulatory liaison with sponsors, investigators, study teams, and the IRB to support timely, compliant research conduct.

Responsibilities include drafting and submitting protocols and amendments, maintaining CTMS records, facilitating regulatory education, preparing

Qualifications

• Bachelor's degree required; experience may substitute education.
• Minimum 2 years in compliance or healthcare field.
• CITI certification within 30 days of hire; SoCRA/ACRP preferred.

Responsibilities

• Prepare and submit IRB documents, amendments, and continuing reviews.
• Act as regulatory liaison with sponsors, investigators, and IRB.
• Maintain regulatory files for IND/IDE and CTMS records.
• Review submissions for accuracy and compliance using checklists.
• Facilitate regulatory education and ensure adherence to SOPs.

Skills

Regulatory compliance

FDA/IND/IDE knowledge

IRB liaison

CTMS proficiency

Documentation management

Education

Bachelor's degree

Tools

CTMS

IRB submission system

Job description

The Research Regulatory Specialist at MCW coordinates and prepares IRB applications, amendments, and continuing reviews for human subjects research to ensure compliance with federal, state, and institutional SOPs. You will act as the regulatory liaison with sponsors, investigators, study teams, and the IRB to support timely, compliant research conduct.

Responsibilities include drafting and submitting protocols and amendments, maintaining CTMS records, facilitating regulatory education, preparing