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Clinical Research Associate
2 months ago
As a Clinical Research Associate at Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, you will play a critical role in ensuring the success of our clinical trials. Your primary responsibility will be to monitor and manage clinical sites, ensuring compliance with regulatory requirements and study protocols.
Key Responsibilities:- Conduct routine monitoring and closeout of clinical sites
- Maintain study files and conduct pre-study and initiation visits
- Liaise with vendors and other stakeholders as assigned
- Ensure the protection of study patients by verifying informed consent procedures and protocol requirements
- Monitor data for missing or implausible data and ensure audit readiness at the site level
- Prepare accurate and timely trip reports and interact with internal work groups to evaluate needs, resources, and timelines
- Act as contact for clinical trial supplies and other suppliers as assigned
- Undertake feasibility work, participate in and follow-up on Quality Control Visits, and assist with training, mentoring, and development of new employees
- Minimum 6 months experience in a related role (e.g., site management, in-house CRA, study coordinator, research nurse, etc.)
- Basic understanding of Regulatory Guidelines
- Ability to work within a project team and good planning, organization, and problem-solving skills
- Good computer skills with a good working knowledge of a range of computer packages
- Valid Driver's License
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution
Fortrea is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.