Contract Clinical Research Associate
Core
Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials to ensure compliance and data accuracy.
Role type
Contract Clinical Research Associate (CRA)
Builds
Clinical trial operations across Australia
Domain
Healthcare / Clinical Research
Required skills
Site monitoring, GCP compliance, source data verification, investigational product accountability, regulatory submissions, TMF management, data query resolution, site selection, protocol training
Preferred skills
Oncology therapeutic experience, independent site management across all trial phases
Technologies
Clinical trial systems, Microsoft Office
Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits; Assess and identify suitable investigative sites; Train site personnel on study protocols and regulatory requirements; Ensure site compliance with GCP and local regulations; Perform source data verification and review clinical documentation; Monitor investigational product accountability and storage; Support submissions to Ethics Committees and Regulatory Authorities; Manage site communications and issue resolution; Review and maintain essential study documentation in the TMF; Facilitate data query resolution; Participate in study team meetings
Seniority
Mid-level, hands-on IC
