Advarra Benefits Overview

Support delivery of GxP consulting services focused on Good Clinical Practice for investigator sites. Assist with audits, assessments, inspection readiness, SOP reviews, audit reporting, client communications, and training materials while developing subject-matter expertise and supporting project teams and process improvements. Extensive travel required.

Reviews, edits, and quality-checks informed consent forms for regulatory and organizational compliance. Applies sponsor and site language, collaborates with IRB stakeholders, mentors editors, attends IRB meetings, maintains human-subjects research knowledge, and supports process improvements. The role requires managing multiple editing projects while ensuring accuracy, clarity, and adherence to U.S. and Canadian clinical research regulations and guidelines.

Provides client service and serves as the primary contact for sponsors, CROs, and research sites. Reviews protocol and site submissions, interprets IRB requirements and decisions, processes protocol changes, manages translation vendors, maintains documentation accuracy, responds promptly to client inquiries, and escalates customer or timeline issues. The role requires experience applying human-subject protection regulations in an IRB or clinical research setting.