Job Description As a Senior CRA at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. Location: Macquarie Park, NSW You will: Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits Act as the main line of communication between project team, Sponsor and the site Ensure that subject recruitment targets and project timelines are met at site level Perform CRF review, source document verification, drug accountability, and query resolution Facilitate the flow of site documents, assist in maintaining study-specific and corporate tracking systems Support Study Startup and Regulatory teams in preparation of draft regulatory and ethics committee submission packages Conduct project-specific training of Investigators, prepare Investigator newsletters Participate in study site audits and client onsite visits, as required Monitor project timelines and patient enrollment, implements respective corrective and preventive measures Support junior Monitors in the query resolution process, including Central Monitoring observation Coordinate safety information flow and protocol/process deviation reporting Perform clinical supplies management with vendors Support site contracting and payments May lead project team calls on a country level
