Jobs at Fortrea

Supports clinical trial site startup and maintenance activities by collecting, reviewing, tracking, and filing essential regulatory documents. Assists with IRB/IEC and regulatory submissions, country-specific patient materials, status reporting, vendor communication, issue escalation, and study system updates. Ensures activities meet client expectations, ICH/GCP, SOPs, budgets, quality standards, and applicable laws. Works under supervision and helps maintain audit-ready study documentation.

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.

Coordinate and manage site start-up activities for clinical trials including site identification, outreach, regulatory/ethics submissions, document collection and quality review, contract and budget negotiation, support for SIVs, TMF maintenance, and stakeholder communication to ensure compliant and timely site activation.

Lead site monitoring and management for clinical studies, ensuring regulatory compliance, patient safety, data integrity, SAE handling, audit readiness, and timely reporting. Serve as lead monitor or local project coordinator, support protocol/CRF development, train junior staff, liaise with vendors, and manage project tasks and travel as required.

Lead site monitoring and management for clinical studies, ensuring protocol compliance, patient safety, data integrity, SAE reporting, audit readiness, and timely monitoring reports. Serve as lead monitor or local project coordinator, assist with protocol/CRF development, vendor liaison, training/mentoring, feasibility, and oversee registry administration. Significant travel required.

Lead site monitoring and management for clinical studies, ensuring regulatory compliance, data integrity, SAE handling, audit readiness, and efficient trial operations. Serve as lead monitor/Local Project Coordinator, mentor junior staff, manage vendors, prepare reports, contribute to protocol/CRF development, and travel frequently for on-site visits.

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.

Manages and monitors clinical trial sites across study phases, ensuring ICH GCP, regulatory, protocol, consent, data integrity, and audit-readiness compliance. Performs source document verification, eCRF review, query resolution, regulatory document maintenance, investigational product accountability, SAE follow-up, trip reporting, site training, and study team coordination. Based in Perth, the role requires independent site monitoring and approximately 60% interstate travel.

Coordinate and support site start-up activities (feasibility, outreach, regulatory submissions, activation) ensuring ICH/GCP and local regulatory compliance. Liaise with sites, CROs, and vendors, manage essential documents/TMF, assist with contracts/budgets, support SIV preparation, perform CRF/source checks, and escalate site risks to meet study milestones.