Affiliated Board Member (ABM)

ABOUT THE ROLE

The Affiliated Board Member (ABM), under the direction of the Executive IRB Chair, conducts regulatory and ethical reviews of research study materials submitted to the IRB, including expedited and convened full Board submissions.

This role requires familiarity with applicable research regulations and ethical standards governing human subjects research. The ABM independently evaluates study materials for regulatory and ethical considerations, provides informed input during the IRB review process, and supports accurate, timely, and well-documented IRB determinations.

The ABM may also participate as a voting member during convened Board meetings, as applicable, and contribute to IRB training, quality improvement, regulatory communications, educational initiatives, and other activities that support Univo’s IRB programs.

WHAT YOU’LL DO

• Conduct detailed reviews of client-submitted research materials, including expedited and convened full Board submissions, to evaluate compliance with applicable federal, state, and local regulations, ethical standards, and institutional policies.
• Evaluate research submissions and identify regulatory, ethical, or operational considerations requiring clarification or additional attention.
• Perform initial administrative reviews of submission materials to confirm accuracy, completeness, and readiness for IRB review.
• Communicate professionally with investigators, sponsors, institutional officials, and internal Operations team members to obtain clarification, resolve submission issues, and request missing documentation.
• Draft professional correspondence regarding IRB determinations, requests for clarification, required revisions, and other Board-related communications.
• Maintain complete and accurate documentation of review activities and IRB determinations in accordance with departmental policies and record-retention requirements.
• Serve as a resource regarding general regulatory information, submission requirements, forms, and IRB procedures.
• Prepare for and participate in convened Board meetings by reviewing assigned materials, participating in discussions, and voting on Board determinations, as applicable.
• Monitor submission timelines for continuing reviews, study closeout reports, safety-related submissions, and other materials requiring timely IRB action.
• Conduct quality checks of IRB documentation and processes to support consistency with regulatory requirements and internal procedures.
• Participate in training and educational activities to remain current on regulatory requirements, human subjects protection, and IRB best practices.
• Contribute to the development and review of training materials, educational resources, regulatory summaries, newsletters, and other communications related to human subjects protection and IRB initiatives.
• Support the preparation of materials for sponsor discussions, conference presentations, educational activities, and other informational engagements involving IRB programs and oversight.
• Assist with the preparation and maintenance of Board metrics and operational performance data, including review volumes, timelines, and other indicators used for reporting, program evaluation, and leadership review.
• Coordinate with vendors supporting IRB operations, as needed, to support the review process and maintain the quality of submission materials.
• Participate in team meetings and contribute to operational improvements.
• Perform other related duties and responsibilities as assigned by the Executive IRB Chair or other senior IRB leadership.

WHAT YOU’LL BRING

• At least two years of experience in IRB administration, clinical research, research administration, or a related human subjects research role.
• Direct experience conducting or participating in IRB reviews, including expedited, exempt, or convened Board reviews, strongly preferred.
• Clinical research industry experience with a contract research organization, sponsor, academic institution, or research organization will also be considered.
• Knowledge of IRB operations and applicable research regulations governing human subjects protection, including 45 CFR 46, 21 CFR 50, 21 CFR 56, and applicable ICH Good Clinical Practice guidance.
• Experience serving as an IRB, ethics committee, or similar research oversight committee member preferred.
• Bachelor’s degree preferred. A master’s degree, PhD, RN credential, or other relevant clinical or research credential is strongly preferred.
• Completion of required research training, including Good Clinical Practice and Human Subjects Protection certification.
• Strong analytical, critical-thinking, and problem-solving skills.
• Excellent written and verbal communication skills.
• Strong attention to detail when reviewing study materials and documenting IRB activities.
• Excellent organizational skills and the ability to manage multiple submissions and deadlines simultaneously.
• Ability to interact professionally with investigators, sponsors, Board members, institutional officials, and other external stakeholders.
• Ability to work independently while collaborating effectively with internal teams.
• Ability to adapt to changes in regulatory requirements, policies, and procedures.
• Commitment to ethical conduct and the protection of human research participants.
• Proficiency with Microsoft Office Suite, including Word, Outlook, Excel, and PowerPoint.
• Experience with Microsoft Teams, electronic IRB management systems, research administration platforms, or other cloud-based business systems preferred.

COMPENSATION

• The anticipated base salary range for this position is $90,000–$110,000 annually. Actual compensation will be determined based on the candidate’s relevant experience, skills, qualifications, and other job-related factors. This position is also eligible for Univo’s comprehensive employee benefits package.

PHYSICAL REQUIREMENTS

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.