IRB & Research Regulatory Specialist

Medical College of Wisconsin; Milwaukee (WI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health care coverage

403B retirement plan

Paid vacation/holidays

Tuition reimbursement

Parental leave

EFAP

Pet insurance

Job summary

Medical College of Wisconsin in Milwaukee seeks a Research Regulatory Specialist to gather regulatory documents and prepare IRB applications, amendments, and continuing reviews for human subject research. You will liaise with sponsors, investigators, and the IRB to support compliant study conduct.

The role emphasizes accurate document drafting, submission to the IRB system, and oversight of regulatory files for IND/IDE projects.

Qualifications

• Bachelor's degree required.
• 2 years in compliance or healthcare field.
• CITI certification within 30 days of hire.
• SoCRA and ACRP certification preferred.

Responsibilities

• Provide primary administrative support for the preparation of IRB documents and assist in drafting and submitting protocols, amendments, deviations, adverse events, continuing progress reports, and consent documents.
• Submit documents in the institution's electronic IRB system for initial approval, amendments, and continuing progress reports; review for accuracy and compliance.
• Support investigators with Investigator-Initiated IND/IDE applications and maintain IRB and FDA regulatory files for each IND/IDE.
• Facilitate study start-up activities with committees and manage ClinicalTrials.gov postings as required.
• Collaborate with Research Managers, Research Nurses, and Research Coordinators to complete all regulatory needs for assigned protocols.
• Identify and resolve problems related to protocol implementation and communicate issues to supervisors and investigators.
• Ensure regulatory activities comply with federal/state laws and SOPs.
• Assist with development of program materials including educational content, marketing materials, websites, forms and reports.
• Maintain program timelines by tracking deadlines and using CTMS to meet regulatory requirements; collect and disseminate data to stakeholders.
• Coordinate regulatory education notifications to study team members.
• Work with principal investigators to develop databases and files for the research program.
• Other duties as assigned.

Skills

Excellent communication

Critical thinking

Regulatory compliance knowledge

Education

Bachelor's degree

Job description

Medical College of Wisconsin in Milwaukee seeks a Research Regulatory Specialist to gather regulatory documents and prepare IRB applications, amendments, and continuing reviews for human subject research. You will liaise with sponsors, investigators, and the IRB to support compliant study conduct.

The role emphasizes accurate document drafting, submission to the IRB system, and oversight of regulatory files for IND/IDE projects.