CRA II - Shanghai

As a Clinical Research Associate II at Syneos Health in Shanghai, your role will involve performing a variety of site management activities to ensure regulatory compliance and protocol adherence. You will be responsible for conducting site qualification, initiation, monitoring, and close-out visits, both on-site and remotely. Your key responsibilities will include: - Evaluating site performance and providing recommendations for site-specific actions - Ensuring informed consent procedures are properly documented for each subject/patient - Assessing factors that may impact subject/patient safety and clinical data integrity - Conducting source document reviews and verifying clinical data accuracy and completeness - Managing investigational product inventory and ensuring proper dispensing and administration - Reviewing the Investigator Site File for accuracy and completeness - Documenting activities and maintaining project-specific documentation - Supporting subject/patient recruitment, retention, and awareness strategies - Managing site-level activities and communication to meet project objectives and timelines - Acting as a liaison with study site personnel and ensuring site compliance with requirements - Participating in Investigator Meetings and global clinical monitoring/project staff meetings - Providing guidance on audit readiness standards and preparation for audits - Maintaining knowledge of relevant guidelines, regulations, and company SOPs - Additional responsibilities for Real World Late Phase studies include site support throughout the study lifecycle, chart abstraction activities, collaboration with stakeholders, and training junior staff To qualify for this position, you should have: - A Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements - Good computer skills and ability to embrace new technologies - Excellent communication, presentation, and interpersonal skills - Ability to travel up to 75% on a regular basis Syneos Health is dedicated to developing its employees and creating a supportive and inclusive work environment. With a focus on career development, diversity, and a Total Self culture, Syneos Health aims to be a company where everyone feels valued and can contribute to meaningful work. Join us in our mission to accelerate customer success and make a difference in the lives of patients worldwide. Discover more about Syneos Health at [Syneos Health Website](http://www.syneoshealth.com).,