Clinical Research Associate Entry (Melbourne)
Core
Conduct on-site monitoring visits for clinical research sites to ensure compliance with protocols and regulations.
Role type
Entry-level Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for biopharma clients
Domain
Clinical Research / Biotechnology / Pharmaceuticals
Required skills
site monitoring, protocol compliance, medical record verification, regulatory document review, adverse event reporting, patient recruitment assessment, investigational product accountability
Preferred skills
study coordinator experience, therapeutic area knowledge
Technologies
GCP, SOPs, Case Report Forms (CRF)
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits; Verify investigator qualifications and resources; Review medical records and source documentation; Verify subject eligibility; Review adverse events and concomitant medications; Assess patient recruitment and retention; Complete monitoring reports and follow-up letters.
Seniority
Entry-level, training-focused IC
