IRB Analyst II - Human Subjects Compliance & QA

Saint Louis University; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Saint Louis University is seeking an IRB Analyst II to coordinate daily processing of research protocols and assist the IRB and HRPP in review management. You will perform audits, monitor compliance, and support staff training. The role involves facilitating central IRB reviews, ensuring adherence to FDA, OHRP, ICH/GCP rules, and preparing meeting materials.

Strong analytical and communication skills are essential, with teamwork and confidentiality. Scheduled weekly hours are 40.

Qualifications

• Bachelor's degree required; CIP certification preferred.
• Two or more years of experience in human subjects research or related monitoring.
• Familiarity with IRB processes, AAHRPP standards, and federal regulations.

Responsibilities

• Reviews and processes exempt and expedited protocol submissions as an IRB designee.
• Coordinates the review process of protocol submissions with IRB reviewers and ancillary office reviewers.
• Determines difficulty level of protocol issues and regulatory determinations.
• Prepares protocols for IRB action and delineates revision requirements.
• Reviews investigators' responses and makes decisions for approval.
• Assists with training HRPP staff and monitors compliance across protocols.
• Facilitates review of central IRBs, external IRBs, and single IRB submissions.
• Coordinates IRB meetings, prepares agenda, and documents review determinations.

Skills

Regulatory compliance

ICH/GCP guidelines

HIPAA knowledge

Analytical skills

Verbal and written communication

Education

Bachelor's degree

Master's degree

CIP Certification

Tools

Microsoft Office

HR database software

Job description

Saint Louis University is seeking an IRB Analyst II to coordinate daily processing of research protocols and assist the IRB and HRPP in review management. You will perform audits, monitor compliance, and support staff training. The role involves facilitating central IRB reviews, ensuring adherence to FDA, OHRP, ICH/GCP rules, and preparing meeting materials.

Strong analytical and communication skills are essential, with teamwork and confidentiality. Scheduled weekly hours are 40.