IRB Analyst II: Lead Human Subjects Compliance

Saint Louis University; Missouri; On-site; USD 60,000 - 85,000; Full time

Job summary

Saint Louis University is seeking an IRB Analyst II to coordinate daily review activities for research protocols and assist with HRPP compliance. You will process exempt and expedited submissions, coordinate IRB actions, and prepare documentation for approvals.

The role includes QA support, policy updates, and staff training to uphold federal regulations and AAHRPP standards. Applicants should have a bachelor’s degree, CIP certification, and at least two years in human subjects research.

Qualifications

• Bachelor’s degree required; CIP certification preferred.
• Two or more years of experience with human subjects research/IRB processes.
• Experience with audit, QA, or HRPP activities is an asset.

Responsibilities

• Reviews and processes exempt/expedited protocol submissions as an IRB designee.
• Coordinates IRB review processes and prepares actions and revisions.
• Coordinates IRB meetings and documents meeting minutes.
• Assists with QA activities, CAPA, and HRPP form/policy updates.
• Supports training and development within HRPP staff and researchers.

Skills

ICH/GCP guidelines

FDA regulations

HIPAA Privacy Rule

HRPP policies

Analytical skills

Verbal and written communication

Confidentiality

Microsoft Office

Custom database software

Education

Bachelor’s degree

Master’s degree

Tools

Microsoft Office

Custom database software

Job description

Saint Louis University is seeking an IRB Analyst II to coordinate daily review activities for research protocols and assist with HRPP compliance. You will process exempt and expedited submissions, coordinate IRB actions, and prepare documentation for approvals.

The role includes QA support, policy updates, and staff training to uphold federal regulations and AAHRPP standards. Applicants should have a bachelor’s degree, CIP certification, and at least two years in human subjects research.