Sr Clinical Research Associate II (SCRA2), FSP - Sydney or Melbourne
Core
Senior Clinical Research Associate responsible for Risk Based Monitoring (RBM), site management, and data integrity for clinical studies.
Role type
Senior IC clinical research associate (monitoring & site management)
Builds
Clinical trial data and patient safety compliance
Domain
Clinical research / Drug development
Required skills
Risk Based Monitoring (RBM), site management, source document review, Case Report Form (CRF) review, Serious Adverse Event (SAE) reporting, regulatory compliance, protocol adherence, data quality monitoring, registry management, feasibility assessment, quality control (QC) visits, investigator recruitment, budget negotiation, clinical trial reporting, training and mentoring
Preferred skills
Local project coordination, clinical trial management system (CTMS) usage, physiology/pharmacology knowledge, Australian regulatory requirements understanding
Technologies
Clinical trial management systems (CTMS), Microsoft Office
Responsibilities
Conduct routine and close-out site monitoring visits; verify informed consent and protocol adherence; review source documents and CRFs for data integrity; track and report Serious Adverse Events; manage clinical trial registries; coordinate investigator recruitment and EC submissions; negotiate study budgets; assist in protocol and CRF development; mentor junior staff; prepare trip reports and clinical trial reports.
Seniority
Senior, hands-on IC