To coordinate, provide support and oversee the review and approval process of all research activities involving human subjects to protect their safety, rights, and welfare in compliance with Institutional Review Board (IRB) regulations for the Human Subjects Protections Program.

     • Coordinates all aspects of the collection and review of applications that involve human subjects in research.
     • Conducts pre-reviews of applications submitted to the IRB, including new study protocols, continuing reviews, and modifications to approved studies to determine consistency with federal regulations, institutional policies, and IRB requirements.
     • Provides guidance and professional support to the university’s Human Subjects Protections Program and communicates with the Institutional Review Board regarding the procedural and regulatory requirements of human subjects’ research.
     • Plans, reviews, assesses, and recommends to the IRB applications of studies that qualify for expedited review procedures versus full Board review.
     • Assesses, reviews and makes determinations for non-regulated studies and studies that are deemed exempt from federal regulatory compliance.
     • Coordinates and processes reliance agreements for multi-site research; conducts local review for studies approved by a non-UTRGV IRB.
     • Conducts pre-review of unanticipated problems and adverse events and makes recommendations to management.
     • Assists in the identification of potential regulatory issues with human subject research protocols, provides technical support and procedural guidance to regulatory or compliance staff, investigators and the IRB.
     • Conducts literature reviews and prepares reports for the IRB regarding scientific, ethical, and existing and proposed regulatory topics.
     • Executes directives resolved by the IRB, including drafting and execution of determinations and applicable compliance findings or action items.
     • Coordinates quality control functions and conducts post-approval monitoring.
     • Coordinates IRB meetings: attends meetings and actively participates in discussions; records Board deliberations by writing and editing meeting minutes.
     • Provides regulatory support to the IRB members.
     • Collaborates with other regulatory committees for ancillary review.
     • Develops and delivers relevant education programs to researchers and IRB members.
     • Develops and maintains templates to assist researchers with their study submissions to the IRB.
     • Liaises with researchers to revise submissions and prepare for final board review.
     • Ensures and maintains accurate records are kept
     • Performs other duties as assigned.