Sr Clinical Research Associate I Sydney, Melbourne, or Perth
Core
Senior Clinical Research Associate responsible for site monitoring, site management, and registry administration for clinical studies.
Role type
Senior IC Clinical Research Associate (Site Monitoring & Management)
Builds
Clinical trial data integrity and regulatory compliance at study sites
Domain
Clinical Research / Pharmaceutical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical site monitoring, Study site management, Registry administration, SAE reporting, Protocol adherence, Source document review, CRF review, Vendor liaison, Investigator recruitment, Budget negotiation, Regulatory compliance knowledge, Drug development process understanding
Preferred skills
Local project coordination, Project management, Medical/Clinical background, Data analysis, Technical writing
Technologies
Clinical trial data management systems, Computer packages
Responsibilities
Conduct routine and closeout monitoring visits, Ensure informed consent and protocol adherence, Review source documents and CRFs for data integrity, Manage clinical trial supplies and vendors, Recruit potential investigators, Track and report Serious Adverse Events (SAEs), Assist in protocol and CRF development, Coordinate registry management, Perform quality control visits, Train and mentor junior staff
Seniority
Senior, hands-on IC with line management responsibilities
