IRB Operations Lead - Regulatory & Research Compliance

Hennepin Healthcare Research Institute; Minneapolis (MN); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Hennepin Healthcare Research Institute in Minneapolis seeks an experienced IRB Analyst to support HRPP leadership and manage human-subjects research compliance. The role applies SOPs, FDA/IRB regulations, and ethical principles to protect participants.

This hybrid position requires periodic onsite presence on the HCMC campus, with collaboration across HRPO, IRB, and researcher teams to process submissions and ensure timely, accurate reviews.

Qualifications

• Basic knowledge of federal/state regulations pertaining to human subjects research, ICH GCP, HIPAA.
• Experience with clinical research and medical terminology.
• Strong written and oral communication skills.

Responsibilities

• Follow HRPO workflows and operations and provide backup when needed.
• Support IRB members and researchers with submissions and processes.
• Screen/review submissions for completeness and conformance with SOPs.
• Prepare and communicate IRB determinations and meeting minutes.

Skills

Regulatory knowledge

HIPAA knowledge

MS Office

Written communication

Team collaboration

IRB management systems

Education

Baccalaureate degree

3 years IRB/clinical research experience

Tools

Cayuse HE

Job description

Hennepin Healthcare Research Institute in Minneapolis seeks an experienced IRB Analyst to support HRPP leadership and manage human-subjects research compliance. The role applies SOPs, FDA/IRB regulations, and ethical principles to protect participants.

This hybrid position requires periodic onsite presence on the HCMC campus, with collaboration across HRPO, IRB, and researcher teams to process submissions and ensure timely, accurate reviews.