IRB Compliance Analyst – Human Subjects Research

The University of Toledo; Ottawa Hills (OH); On-site; USD 40,000 - 49,000; Full time

Job summary

The University of Toledo seeks an Associate Compliance Analyst, IRB to support leadership in ensuring compliance with federal, state, and institutional rules governing human subjects research.

The role focuses on protocol pre-review, analysis, and disposition of pre-review materials, including applications and informed consents, with responsibility for educating investigators and IRB members on regulatory expectations. Independent judgment and confidentiality are essential.

Qualifications

• Bachelor's degree required; two to three years of professional or research experience in human subjects research and regulatory compliance.
• Knowledge of DHHS/OHRP, FDA, HIPAA regulations, informed consent processes, and regulatory guidance and standards.
• High-level organization skills with ability to manage multiple tasks to meet deadlines.
• Ability to work independently and in a team-oriented environment.
• Experience handling confidential information and research contracts.
• Willingness to pursue further education and aim for CIP certification within three years.

Responsibilities

• Perform protocol pre-review and analysis for human subject research oversight.
• Review and disposition materials related to pre-reviews, including applications and informed consent documents.
• Provide guidance on regulatory obligations and ethical conduct of human subjects research to investigators and IRB members.
• Educate staff and IRB members on regulatory requirements and ongoing compliance.
• Exercise independent discretion while contributing as a team member and safeguard confidential information.
• Support other areas of research compliance as needed and assist in training staff.

Skills

Regulatory compliance

Human subjects research

Data gathering & reporting

Confidential information handling

Teamwork

Organization skills

CIP certification pursuit

Education

Bachelor's Degree

Master's or J.D. degree

Job description

The University of Toledo seeks an Associate Compliance Analyst, IRB to support leadership in ensuring compliance with federal, state, and institutional rules governing human subjects research.

The role focuses on protocol pre-review, analysis, and disposition of pre-review materials, including applications and informed consents, with responsibility for educating investigators and IRB members on regulatory expectations. Independent judgment and confidentiality are essential.