Clinical Research Specialist II
2 weeks ago
Company Overview:
SYD Fortrea Australia Pty Ltd is a premier global contract research organization (CRO) committed to scientific excellence and innovation in clinical development. With extensive experience spanning over three decades, we offer a comprehensive suite of clinical development, patient access, and technological solutions across a multitude of therapeutic areas. Our dedicated workforce of over 19,000 professionals operates in more than 90 countries, driving advancements in drug and device development for the benefit of partners and patients worldwide.
Our Mission:
At SYD Fortrea, we are pioneers in the biopharmaceutical sector, dedicated to transforming healthcare through groundbreaking research and a steadfast commitment to quality. We are looking for passionate individuals who are eager to make a significant impact in the realm of clinical research.
Why Choose SYD Fortrea?
Culture of Innovation: Be part of a vibrant team that champions creativity and innovative thinking.
Professional Development: Benefit from ongoing training and development opportunities to enhance your career trajectory.
Work-Life Integration: Experience a flexible work environment that supports both your professional and personal aspirations.
Role Summary:
As a Clinical Research Associate II at SYD Fortrea, you will play a pivotal role in overseeing global clinical trials, ensuring adherence to protocols and maintaining the highest standards of data integrity. This position offers the opportunity to collaborate closely with dedicated sponsors and engage in groundbreaking trials that have the potential to significantly enhance patient health outcomes.
Key Responsibilities:
- Trial Monitoring: Ensure compliance with study protocols, amendments, and regulatory standards.
- Site Visits: Conduct pre-study, initiation, routine monitoring, and close-out visits to ensure proper trial execution.
- Site Management: Oversee regulatory submissions, participant recruitment, CRF completion, and resolution of data queries.
- Communication: Facilitate effective communication among sponsors, investigators, and stakeholders to ensure seamless trial operations.
- Data Accuracy: Guarantee precise data collection, documentation, and timely report submissions.
- Documentation: Assist in the development and review of study protocols, CRFs, and informed consent documents.
- Training: Provide training to site personnel to ensure compliance with trial protocols and objectives.
- Risk Assessment: Identify and manage risks to uphold trial integrity and participant safety.
Qualifications:
- Educational Requirement: Bachelor’s degree in a scientific or health-related discipline (advanced degree preferred).
- Experience: Demonstrated expertise in clinical research site management and monitoring, preferably within a CRO or pharmaceutical environment.
- Regulatory Acumen: Strong knowledge of ICH-GCP guidelines and clinical trial regulatory requirements.
- Monitoring Expertise: Proven track record in monitoring Oncology phase I, II, or III global studies.
- Skills: Exceptional communication, organizational, and time management skills.
- Travel Flexibility: Willingness to travel as necessary for site monitoring activities.
Ready to contribute to the evolution of healthcare? SYD Fortrea is seeking motivated individuals who are passionate about overcoming challenges in clinical trials. Our commitment is to innovate the development process, ensuring the rapid delivery of transformative ideas and therapies to patients in need. Embrace a collaborative environment that fosters personal growth and enables you to make a meaningful impact on a global scale.
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