Clinical Research Associate (Home-based, Adelaide)
Core
Conduct on-site clinical monitoring visits (qualification, initiation, closeout) for 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, pharmaceutical, and medical device companies
Domain
Clinical Research / Clinical Trials
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 for research sites; Verify investigator qualifications and site resources; Review medical records and source documentation against CRF data; Verify subject eligibility and enrollment; Review adverse events and concomitant medications; Assess patient recruitment and retention success; Complete monitoring reports and follow-up letters.
Seniority
Entry-level to Mid-level (training provided)
