IRB Program Manager: Research Compliance & Submissions

Jobtailor; Cleveland (OH); On-site; USD 52,000 - 72,000; Full time

Job summary

Jobtailor in Cleveland, OH seeks an IRB Administrator to conduct administrative and regulatory reviews of human subjects’ research. You will guide principal investigators, manage protocol submissions in WebKit, and coordinate expedited and full IRB reviews to ensure compliance and efficiency.

Responsibilities include drafting correspondence, preparing meeting materials, and supporting convened board operations.

Qualifications

• Requires 2 years of experience in research administration, clinical research, regulatory compliance, or related field, OR 6+ years with clinical research programs and/or human subject protection
• Ability to work collaboratively in a team while independently managing tasks
• Willingness to learn and adapt to new regulations affecting human subjects’ research
• Commitment to confidentiality and ethical standards in research administration
• Strong organizational and communication skills
• Bachelor’s degree preferred in biology, public health, clinical research, regulatory affairs, social sciences or related field
• Familiarity with IRB processes or human subjects’ research preferred
• Regulatory clinical trials experience preferred
• Ability to work in a stationary position for extended periods
• Ability to operate computer and office equipment
• Ability to act in stressful environments
• Critical thinking and decisive judgment
• Ability to work with minimal supervision
• Demonstrated team and problem-solving skills
• Must follow PPE precautions and influenza vaccination or exemption
• Post-offer testing for controlled substances may be required

Responsibilities

• Conduct comprehensive administrative and regulatory reviews of human subjects’ research studies
• Provide guidance to principal investigators and study teams
• Manage research protocol submissions in WebKit from intake through final review
• Request revisions or clarifications from investigators
• Facilitate expedited reviews and route submissions for full IRB board review
• Review expedited and exempt IRB submissions
• Perform pre-review assessments of greater-than-minimal-risk studies
• Provide regulatory guidance to non-office IRB members
• Assist with administrative duties for convened board meetings
• Serve as primary liaison between IRB office and assigned institutes
• Review and process new studies, amendments, and other protocol submissions
• Compose correspondence to study teams and evaluate PI responses
• Prepare agendas, materials, and draft IRB minutes
• Monitor quorum and voting outcomes
• Foster communication between IRB and study teams
• Develop and maintain educational resources for IRB staff and study teams
• Participate in daily IRB office operations and support teammates
• Perform other duties as assigned

Skills

Regulatory compliance

Team collaboration

Organizational skills

Communication skills

Critical thinking

Problem solving

Confidentiality

Adaptability

Education

Bachelor’s degree in biology/public health/related field

Tools

WebKit System

Office equipment

Job description

Jobtailor in Cleveland, OH seeks an IRB Administrator to conduct administrative and regulatory reviews of human subjects’ research. You will guide principal investigators, manage protocol submissions in WebKit, and coordinate expedited and full IRB reviews to ensure compliance and efficiency.

Responsibilities include drafting correspondence, preparing meeting materials, and supporting convened board operations.