Clinical Research Associate (Home-based, Sydney)
Core
Conduct on-site monitoring visits for clinical research sites to ensure compliance with protocols and regulations.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for biotechnology and pharmaceutical clients
Domain
Clinical Research / Biotechnology / Pharmaceuticals
Required skills
Clinical monitoring, regulatory compliance (GCP/SOPs), site qualification, source data verification, adverse event reporting, patient recruitment assessment
Preferred skills
Study coordinator experience, clinical research coordinator experience, knowledge of clinical monitoring practices
Technologies
Case Report Forms (CRF), Electronic Data Capture (EDC) systems, regulatory databases
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.
