CRA II / Senior CRA

🔥 31 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

Where this job comes from

Posted on ICON plc's careers page, not through a job board

First seen by Remote Rocketship 31 minutes ago

Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Perform site qualification, initiation, monitoring and closeout activities as assigned • Contribute to clinical trial monitoring activities and take responsibility for deliverables • Verify protocol, GCP and regulatory compliance and participant protection • Review source data, essential documents and site processes for accuracy and completeness • Identify and follow up findings, risks and corrective actions • Maintain clear communication with investigators, site staff and study teams

🎯 Requirements

• Relevant life sciences, healthcare or clinical research qualification, or equivalent relevant clinical research experience • Minimum of 2 years of experience as a Clinical Research Associate • In-depth knowledge of clinical trial processes, regulations, and ICH Good Clinical Practice (GCP) guidelines • Knowledge of ICH Good Clinical Practice (GCP), clinical trial conduct and site monitoring requirements • Practical experience with site monitoring or site management appropriate to the level of role • Experience performing site qualification, initiation, monitoring and closeout activities as assigned • Experience verifying protocol, GCP and regulatory compliance and participant protection • Therapeutic area expertise relevant to assigned studies • Experience with risk based monitoring or centralised monitoring approaches • Experience with clinical trial management systems (CTMS), electronic data capture (EDC) and electronic trial master file systems • Willingness to travel as required (approximately 60%) • Legal right to work in Australia

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways • Approximately 60% travel

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