Institutional Review Board Program Manager

The Institutional Review Board (IRB) Program Manager plays a critical role in ensuring compliance with institutional, federal, and state regulations governing human subjects' research. Conducts comprehensive reviews of human subject research studies, providing expert guidance to principal investigators (PIs) and study teams, and facilitates ethical research practices.

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.

Pay Range

Minimum Annual Salary: $69,600.00

Maximum Annual Salary: $106,132.50

The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic's benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).

Cleveland Clinic Health System is pleased to be an equal employment employer: Women / Minorities / Veterans / Individuals with Disabilities