Clinical Research Associate II
19 hours ago
About SYD Fortrea Australia Pty Ltd
">We are a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. Our wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas enables us to transform drug and device development for partners and patients across the globe.
Innovative Career Opportunities
- Professional Growth: Access continuous professional development opportunities to advance your career as a Clinical Research Associate at SYD Fortrea Australia Pty Ltd.
- Work-Life Balance: Enjoy a flexible work schedule that lets you balance your professional and personal life.
Role Overview
As a Clinical Research Associate at SYD Fortrea Australia Pty Ltd, you'll be at the forefront of global clinical trials, ensuring compliance and maintaining top-tier data integrity. This role gives you the chance to work directly for a dedicated sponsor and be involved in cutting-edge trials that could significantly improve patient health outcomes.
Main Responsibilities
- Monitor Clinical Trials: Ensure studies adhere to protocols, amendments, and regulatory requirements.
- Conduct Site Visits: Perform pre-study, initiation, routine monitoring, and close-out visits.
- Manage Study Sites: Track regulatory submissions, recruitment, CRF completion, and data query resolution.
- Effective Communication: Liaise with sponsors, investigators, and stakeholders for smooth trial execution.
- Data Integrity: Ensure accurate data collection, documentation, and report submissions.
- Documentation Preparation: Assist in creating and reviewing study protocols, CRFs, and informed consent forms.
- Training and Support: Provide training to site staff for compliance with trial protocols and objectives.
- Risk Management: Evaluate and manage risks to ensure trial integrity and participant safety.
Qualifications and Requirements
- Educational Background: Bachelor's degree in a scientific or health-related field (advanced degree preferred).
- Experience: Advanced knowledge in clinical research site management and monitoring in Australia, ideally within a CRO or pharmaceutical setting.
- Regulatory Knowledge: Strong understanding of ICH-GCP guidelines and clinical trial regulatory requirements.
- Trial Monitoring: Proven success in monitoring Oncology phase I, II, or III global studies.
- Skill Set: Excellent communication, organizational, and time management abilities.
- Travel: Willingness to travel as needed for site monitoring.
About Your Role and Benefits
The estimated annual salary for this position is around $80,000 - $110,000 AUD based on your level of experience and qualifications. You will also have access to benefits including hybrid working options, flexible work arrangements, and career growth opportunities.
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