Note: The job is a remote job and is open to candidates in USA. reputed company is a healthcare organization focused on advancing healthcare and reputed company the patient experience. The Institutional Review Board Program Manager will ensure compliance with institutional, federal, and state regulations for human subjects' research while managing protocol submissions, supporting IRB reviews, and guiding investigators and study teams. The role also supports convened board meetings, correspondence, educational resources, and daily IRB office operations.
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 reputed company 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 reputed company 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
Skills
• 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
• 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
• 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
Benefits
• A hybrid schedule from 8:00 a.m. – 5:00 p.m., with 3–4 days per week on-site at Main Campus.
• Opportunities for professional growth.
Company Overview
• reputed company is a non-profit medical center that combines clinical and hospital care with research and education. It is a sub-organization of reputed company. It was founded in 1921, and is headquartered in Cleveland, Ohio, USA, with a workforce of 10001+ employees. Its website is http://my.clevelandclinic.org.
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