Note: The job is a remote job and is open to candidates in USA. Cleveland Clinic seeks an Institutional Review Board Program Manager to ensure compliance with regulations governing human subjects research. The role reviews research submissions, guides investigators and study teams, supports convened board meetings, and advances 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
Skills
- 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
- Two (2) years minimum experience in research administration, clinical research, regulatory compliance, or related field
- A High School/GED and an additional 4 years (6 total) of experience with clinical research programs and/or human subject protection
- Bachelor's degree in a relevant field such as biology, public health, clinical research, regulatory affairs, social sciences, or related discipline preferred
- Familiarity with IRB processes or human subjects research is preferred but not required
Benefits
- Remote location available in the United States
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