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Biotech
The Senior Clinical Research Associate I monitors clinical study sites, ensures compliance, manages data integrity, and mentors junior staff while traveling extensively to support clinical trials.
Biotech
Manage and monitor clinical trial sites per SOPs and ICH GCP, including site initiation, routine and close-out visits. Verify informed consent, perform 100% source data verification and eCRF review, maintain regulatory/eTMF documentation, track IP and SAEs, prepare trip reports, support audit readiness, and provide site and staff training. Travel approximately 60%; based in Melbourne, Adelaide or Perth.
Biotech
The Clinical Research Associate II manages and monitors clinical trials, ensuring compliance with regulations and data integrity while providing support to study sites and teams.
Biotech
Oversee RA, IRB/EC, and Third Body submissions for APAC clinical trials, manage submission strategy/timelines, QC regulatory packages, liaise with stakeholders and clients, support audits, mentor junior staff, and improve processes to ensure compliant, on-time study startup deliverables.
Biotech
Coordinate and manage site start-up activities for clinical studies, ensuring regulatory compliance (ICH/GCP, IRB/IEC), site selection, document collection, site activation, vendor coordination, contract and budget negotiations, TMF maintenance, and stakeholder communication. Serve as primary site contact, mentor junior staff, and support CRA activities through activation and closeout as needed.
Biotech
Site Navigators coordinate site-level activities during clinical study start-up, ensuring regulatory compliance, site management, and effective collaboration between sponsors and investigative sites.
Biotech
Site Navigator II coordinates site-level activities during clinical study start-up, ensuring regulatory compliance, site support, and collaboration among stakeholders.
Biotech
Lead site monitoring and management for clinical trials, ensuring regulatory compliance, patient safety, and data integrity. Perform study initiations, routine and close‑out visits, SAE tracking, CRF review, vendor liaison, and prepare trip reports. Act as lead monitor/Local Project Coordinator, support protocol development, training, QC visits, feasibility, and investigator engagement. Travel up to 40%.
