Start-up Associate (Clinical Trial Associate) - Sydney
Core
Primary contact for investigative sites to collect regulatory and investigator documents, ensuring timely submissions to IRB/IEC/Regulatory Authorities for study startup and maintenance.
Role type
Associate Clinical Trial Associate (Regulatory Submissions)
Builds
Regulatory Authority submissions and site readiness documentation
Domain
Clinical Trials / Life Sciences
Deliverable
client delivery
Required skills
Regulatory legislation knowledge, ICH/GCP guidelines, document compilation, quality review, stakeholder liaison, risk escalation
Preferred skills
Informed Consent Form adaptation, contract negotiation support, status reporting
Technologies
Fortrea
Responsibilities
Collect and track necessary documents for site activation and maintenance, prepare and submit documents to IRB/IEC/Regulatory Authority, liaise with internal and external vendors, review final submission documents, update study documents for personnel changes or amendments, adapt patient-facing materials to country-specific requirements, escalate study issues and risks to leads.