Clinical Research Associate: Monitor Trials & Compliance …, City of Sydney

The Clinical Research Associate is responsible for managing and monitoring clinical trials to ensure they are conducted in compliance with study protocols, ICH-GCP, and applicable regulations. This includes site selection, initiation, monitoring, and close-out activities, while ensuring data quality and patient safety. The role reports to the Clinical Project Manager. Key Responsibilities
- Identify, assess, and initiate investigational sites
- Conduct feasibility, pre-study, initiation, monitoring, and close-out visits
- Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements
- Perform source data verification and ensure data accuracy and completeness
- Monitor patient recruitment and support sites in meeting targets
- Ensure proper reporting of adverse events and protocol deviations
- Manage investigational product handling, storage, and accountability
- Maintain study documentation (TMF/eTMF, Investigator Files)
- Write monitoring reports and follow-up communications
- Collaborate with project teams, sponsors, and site staff
- Support audits/inspections and mentor junior CRAs Requirements
- Degree in a scientific field
- Minimum 2 years’ CRA or clinical trial monitoring experience
- Strong knowledge of ICH-GCP, ISO14155, and clinical trial processes
- Good English and Microsoft Office skills
- Strong organizational, communication, and problem-solving abilities
- Ability to work independently and in a team What we offer We offer a market-competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company. #J-18808-Ljbffr Apply on Kit Job: kitjobau.com/job/3qw6cq