IRB Analyst II

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.

Duties

In this role, your PRIMARY DUTIES would include shepherding research protocol submissions through the Institutional Review Board (IRB) review process. This includes:

• 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.
• Determining what level of IRB review is required and assigning and distributing study materials to IRB reviewers and meeting agendas.
• Preparing and distributing IRB determination letters.
• 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.
• Assisting with the preparation of consent forms including highly customized consents and other routine study documents.
• Working effectively with team, proactively selecting work items to promote workload balance, providing timely updates to workload tracker.
• May assist leadership on resolving regulatory or operational difficulties or in representing the team on IRB or other meetings.
  
  

SUCCESSFUL CANIDATES will have:

• High school diploma or general education degree (GED) required, combined with at least 4 years’ experience working as a research oversight professional.
• At least 2 years’ experience in IRB, clinical research, or similar setting.
• Demonstrated ability to follow standard operating procedures.
• Demonstrated ability to work cohesively in a team structure in a fully remote environment.
• Strong written and oral communication skills, and customer service skills.
  
  

PREFERRED QUALIFICATIONS include:

• Bachelor’s degree in a related field, such as biomedical or social sciences, research preferred.
• Knowledge of Federal Regulations (FDA, DHHS) and ICH Guidelines for clinical trials.
• Excellent customer service skills.
  
  

Sabai Global is an Equal Opportunity Employer. Candidates needing assistance with the application process, due to differing abilities, should contact jcarroll@sabaiglobal.com.

Location eligibility applies. Candidates must reside in a US state where the company is authorized to hire.