Institutional Review Board Program Manager

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Job Title

Institutional Review Board Program Manager

Location

Cleveland

Facility

Cleveland Clinic Main Campus

Department

RES Institutional Review Board-Research Innov and Educ

Job Code

T31155

Shift

Days

Schedule

8:00am-5:00pm

Job Summary

Job Details

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.

A caregiver in this role works a hybrid schedule from 8:00 a.m. – 5:00 p.m., with 3–4 days per week on-site at Main Campus.

A caregiver who excels in this role will:

• 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.

Minimum qualifications for the ideal future caregiver include:

• 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

Preferred qualifications for the ideal future caregiver include:

• 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

Physical Requirements:

• Requires critical thinking skills, decisive judgment and the ability to work with minimal supervision.

• Must be able to take appropriate action in a stressful environment.

• Demonstrated team and problem-solving skills.

• Ability to perform work in a stationary position for extended periods. 

• Ability to operate a computer and other office equipment.

Personal Protective Equipment:

• Follow standard precautions using personal protective equipment as required.

The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our drug free environment. All offers of employment are followed by testing for controlled substances.

Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program, which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.

Decisions concerning employment, transfers and promotions are made upon the basis of the best qualified candidate without regard to color, race, religion, national origin, age, sex, sexual orientation, marital status, ancestry, status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility. 

If applying for a Florida position, please see the following website for more information on the background screening requirements required by the Agency of Health Care Administration: https://info.flclearinghouse.com/

Please review the Equal Employment Opportunity poster. 

Cleveland Clinic is pleased to be an equal employment opportunity employer.