Take your career to the next level and lead challenging study activation process in Australia. You will support clinical research teams and ensure PSI projects start smoothly and on time. We’re looking for a SSU Specialist I on an 12-month contract to support our increased workload. This is a great opportunity for someone looking to gain hands-on experience in clinical research or transition into Study Startup role. Our office is based in Macquarie Park, Sydney. You will: Maintains study-specific and corporate startup tracking systemsFacilitates site budgets and contract negotiationsSupports site regulatory document collectionUnder supervision, may prepare initial and amendment submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable)Communicates with the project team and investigational sites throughout the entire duration of the studyDevelops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestonesMay review study specific translationsSupervises Trial Master File (TMF) maintenance throughout the study startup phase
