Portfolio Company Positions

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 in a fully remote or hybrid role (if local to the St. Louis, MO area).

In this role, your PRIMARY DUTIES would include:

• Overall responsibility for 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.
• 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, and minutes for convened IRB meetings.
• Reviewing responses to IRB determination letters and assigning to the IRB as needed.
• Providing superior customer service, to include submission assistance.
• Conferring with leadership to resolve regulatory or operational difficulties.
• Notifying supervisor of any deviations from established policies and procedures.
• Keeping supervisor informed of activities.
  
  

SECONDARY DUTIES include:

• Maintaining electronic records related to IRB reviews, IRB meetings, and IRB members.
• Maintaining electronic records related to study sites and study contacts.
• Assisting leadership with preparing and updating standard operating procedures, forms, and other regulatory documents.
• Leading special projects and performing other duties as assigned.
  
  

SUCCESSFUL CANIDATES will have:

• Bachelor’s degree or at least 3 years of experience working as a research oversight professional.
• Certification as an IRB or clinical trial oversight professional (e.g. CIP, CIM, CCRC, CCRP) preferred.
• At least 2 years working as a research oversight professional or in clinical research.
• A working knowledge of the Common Rule, FDA regulations and ICH GCP.
• Strong written and oral communication skills.
• Strong customer service skills.
• Demonstrated ability to work in a team structure.
• Demonstrated ability to follow standard operating procedures.
• Working familiarity with standard office information technology software.
  
  

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