SABAI GLOBAL, a leader in providing Institutional Review Board (IRB) services, works diligently to protect the rights, safety and welfare of human research participants who participate in research studies. We have an opening for an IRB ANALYST II in a fully remote role.
In this role, your PRIMARY DUTIES would include shepherding research protocol submissions through the Institutional Review Board (IRB) review process. This includes:
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Assessing IRB submissions for compliance with federal regulations, ethical principles, applicable laws and Sabai policy requirements, and corresponding with IRB members, Investigators, Sponsors/CROs to resolve issues. This could include complex or highrisk submissions, under direction of higherlevel personnel (Senior IRB Analyst) or leadership.
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Determining what level of IRB review is required and assigning and distributing study materials to IRB reviewers and meeting agendas.
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Preparing and distributing IRB determination letters.
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Providing superior customer service, to include submission assistance or client relations in partnership with client services. Appropriately escalating serious customer issues to higherlevel personnel or leadership.
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Assisting with the preparation of consent forms including highly customized consents and other routine study documents.
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Working effectively with team, proactively selecting work items to promote workload balance, providing timely updates to workload tracker.
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May assist leadership on resolving regulatory or operational difficulties or in representing the team on IRB or other meetings.
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High school diploma or general education degree (GED) required, combined with at least 4 years’ experience working as a research oversight professional.
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At least 2 years’ experience in IRB, clinical research, or similar setting.
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Demonstrated ability to follow standard operating procedures.
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Demonstrated ability to work cohesively in a team structure in a fully remote environment.
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Strong written and oral communication skills, and customer service skills.
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Bachelor’s degree in a related field, such as biomedical or social sciences, research preferred.
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Knowledge of Federal Regulations (FDA, DHHS) and ICH Guidelines for clinical trials.
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Excellent customer service skills.
Sabai Global is an Equal Opportunity Employer. Candidates needing assistance with the application process, due to differing abilities, should contact [email protected].
Location eligibility applies. Candidates must reside in a US state where the company is authorized to hire.
From our initial founding, Sabai has protected the safety, rights and welfare of those who participate in clinical trials and those that conduct the research. We began by providing biosafety services and oversight for institutions, and our uniquely personal approach to deep expertise and white-glove service soon drove expansion into IRB review and consulting. Today, we support sponsors and sites across all phases of research and all therapeutic areas, including biologics, human factors, devices and social behavioral research. We deliver a complete suite of services to our pharmaceutical and institution partners. We’re proud to always remain a people-focused company. Through this principle we serve as a true partner to our clients—thoughtfully and expertly curating the best solutions to meet their needs, throughout the clinical trial process. We are Principled. We are Passionate. We are People-first. If all of this resonates with you, we would like to hear about your story.
