Institutional Review Board Program Manager

Cleveland Clinic•Cleveland, OH

1d•Hybrid

About The Position

Join Cleveland Clinic’s Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world. As an Institutional Review Board (IRB) Program Administrator, you will play a critical role in ensuring compliance with institutional, federal, and state regulations governing human subjects’ research. In this role, you will conduct comprehensive administrative and regulatory reviews of human subjects’ research studies, provide guidance to principal investigators (PIs) and study teams, and facilitate ethical research practices. You will manage research protocol submissions received through the WebKit system from initial intake through final review, ensuring submissions meet institutional and federal requirements and communicating directly with investigators to request revisions or clarifications when needed. This position will facilitate expedited review processes to help reduce review timelines and improve efficiency and prepare route submissions for review by the full IRB Board when additional oversight is required. Working with top-tier physicians, bioethicists, scientists, and researchers at a globally recognized healthcare system, you will safeguard human research subjects while contributing to world-class medical innovations.

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 also 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

Nice To Haves

Bachelor’s degree in a relevant field such as biology, public health, clinical research, regulatory affairs, social sciences, or related discipline
Familiarity with IRB processes or human subjects’ research
Regulatory Clinical Trials Experience

Responsibilities

Conduct thorough reviews of IRB submissions (expedited and exempt) to ensure compliance with IRB policies, institutional SOPs, and applicable regulations and ethical principles.
Perform pre-review assessments of greater-than-minimal-risk research studies, providing regulatory guidance and support to non-office IRB members.
Assist with administrative responsibilities associated with convened board meetings.
Act as the primary liaison between the IRB office and assigned institutes, addressing inquiries and offering guidance to study teams.
Review and process various protocol submission types, including new studies and amendments, ensuring adherence to regulatory standards.
Compose detailed correspondence to study teams, clearly communicating concerns, rationales, and technical questions, and evaluates PI responses to IRB-imposed conditions.
Support the preparation of agendas, meeting materials, and draft IRB meeting minutes to ensure compliance with regulatory requirements.
Monitor and document quorum presence and voting outcomes during convened board meetings.
Facilitate communication and resolution of issues between the IRB and study teams, ensuring seamless collaboration and timely follow-up on requests.
Develop and maintain educational resources for IRB office staff and study teams to support the advancement of ethical and compliant research.
Participate in the daily operations of the IRB office, supporting team members and engaging in opportunities for professional growth.
Performs other duties as assigned.