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Responsibilities:

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

Education:

• Bachelor’s degree in a relevant field such as biology, public health, clinical research, regulatory affairs, social sciences, or related discipline preferred.

Complexity of Work:

• Requires critical thinking skills, decisive judgment and the ability to work with minimal supervision.
• Must be able to work in a stressful environment and take appropriate action.
• 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

Work Experience:

• Two (2) years minimum experience in research administration, clinical research, regulatory compliance, or related field.
• Familiarity with IRB processes or human subjects research is preferred but not required.
• Offset: A High School/GED and an additional 4 years (6 total) of experience with clinical research programs and/or human subject protection

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.