Clinical Research Associate Ii

1 month ago

Sydney, Australia Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Why Fortrea?- Innovative Culture: Be part of a dynamic team that values creativity and fresh ideas.- Career Growth: Access continuous professional development opportunities to advance your career.- 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 Fortrea, you'll be at the forefront of global clinical trials, ensuring compliance and maintaining top-tier data integrity. This is your chance to work directly for a dedicated sponsor and be involved in cutting-edge trials that could significantly improve patient health outcomes.

Key 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:
- 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.- Skills: Excellent communication, organizational, and time management abilities.- Travel: Willingness to travel as needed for site monitoring.- Hybrid Working: Happy to work from the Sydney based office 4 days per week for the first 6 months.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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