Institutional Review Board Program Manager

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

• Conduct comprehensive administrative and regulatory reviews of human subjects’ research studies
• Provide guidance to principal investigators and study teams
• Manage research protocol submissions in the WebKit system from initial intake through final review
• Request revisions or clarifications from investigators when needed
• Facilitate expedited review processes and route submissions for full IRB Board review when required
• Conduct thorough reviews of expedited and exempt IRB submissions
• Perform pre-review assessments of greater-than-minimal-risk research studies
• Provide regulatory guidance and support to non-office IRB members
• Assist with administrative responsibilities for convened board meetings
• Act as the primary liaison between the IRB office and assigned institutes
• Review and process new studies, amendments, and other protocol submission types
• Compose correspondence to study teams and evaluate PI responses to IRB-imposed conditions
• Prepare agendas, meeting materials, and draft IRB meeting minutes
• Monitor and document quorum presence and voting outcomes
• Facilitate communication and resolution of issues between the IRB and study teams
• Develop and maintain educational resources for IRB staff and study teams
• Participate in daily IRB office operations and support team members
• Perform other duties as assigned

Requirements

• Two years of experience in research administration, clinical research, regulatory compliance, or related field OR a high school/GED and six years of experience with clinical research programs and/or human subject protection
• Ability to work collaboratively in a team environment while independently managing assigned tasks
• Willingness to learn and adapt to new processes and regulations affecting human subjects’ research
• Commitment to maintaining confidentiality and adhering to ethical standards in research administration
• Strong organizational and communication skills
• Preferred: Bachelor’s degree in a relevant field such as biology, public health, clinical research, regulatory affairs, social sciences, or related discipline
• Preferred: Familiarity with IRB processes or human subjects’ research
• Preferred: Regulatory Clinical Trials Experience
• Ability to perform work in a stationary position for extended periods
• Ability to operate a computer and other office equipment
• Ability to take appropriate action in a stressful environment
• Critical thinking skills and decisive judgment
• Ability to work with minimal supervision
• Demonstrated team and problem-solving skills
• Must follow standard precautions using personal protective equipment as required
• Must comply with the annual influenza prevention program, including vaccination or an approved exemption
• Employment offers are followed by testing for controlled substances

Core Competencies

Demonstrates expertise in conducting administrative and regulatory reviews of human subjects' research studies, providing guidance to principal investigators, and managing research protocol submissions. Strong organizational and communication skills are essential for facilitating IRB processes and supporting research compliance.

Highest-signal resume keywords

• Research Administration Experience
• IRB Processes Familiarity
• Regulatory Compliance Knowledge
• Clinical Research Experience
• Strong Organizational Skills

Hard Skills

• Regulatory Compliance
• Research Protocol Management
• IRB Submission Review
• Critical Thinking
• Problem-Solving

Soft Skills

• Team Collaboration
• Communication Skills
• Adaptability
• Confidentiality Commitment

Industry Keywords

• Human Subjects Research
• Clinical Trials
• Ethical Standards
• Research Administration
• Confidentiality

Tools & Technologies

• WebKit System
• Office Equipment