Experienced CRA - FSO (Tokyo Hybrid)

About the role

Syneos Health is hiring an experienced Clinical Research Associate (CRA) for its Functional Service Provider (FSO) programme, based in Tokyo with a hybrid arrangement. The role covers site qualification, initiation, interim monitoring, site management and close-out, and may involve real-world late-phase studies.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, on-site or remotely, ensuring regulatory, ICH-GCP and protocol compliance
• Evaluate site and site staff performance, escalate serious issues and develop action plans
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• Review source documents and case report forms, resolve queries and verify electronic data capture compliance
• Check investigational product inventory, dispensing and administration, and ensure proper labelling, import and return
• Review the Investigator Site File, reconcile it with the Trial Master File and document activities
• Support recruitment and retention, enter tracking data, and prepare sites for audits
• Attend investigator meetings, project meetings and clinical training, and suggest potential sites
• For real-world late phase: chart abstraction, data collection and collaboration with sponsor affiliates, medical science liaisons and local country staff

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Good computer skills and ability to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage travel of up to 75% regularly

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• Working knowledge of ICH/GCP guidelines, regulations and company SOPs