Job Details

Job Title: Experienced Clinical Research Associate (CRA)
Locations: Tokyo, Japan and Osaka, Japan
Headcount: 1 position per location

Overview
A global clinical research organisation is seeking experienced Clinical Research Associates to support clinical trial delivery across Japan. These roles are based in Tokyo and Osaka and will be responsible for site-level execution and oversight of clinical studies, ensuring compliance with applicable regulations, protocols, and quality standards.

The organisation supports Phase I-IV clinical development programs across a broad range of therapeutic areas and is recognised for its structured approach to clinical operations, strong regulatory compliance, and commitment to data quality.

Key Responsibilities

• Conduct site qualification, initiation, routine monitoring, and close-out visits in accordance with study protocols, SOPs, GCP, and applicable local regulations (including J-GCP)
• Act as the primary point of contact for investigative sites, building effective relationships with investigators, study coordinators, and site staff
• Verify investigator qualifications, training, and site resources, including facilities, laboratories, equipment, and staffing
• Perform source data verification and ensure accurate documentation and data entry in line with protocol and regulatory requirements
• Identify, document, and communicate protocol deviations, ensuring appropriate corrective and preventive actions are implemented
• Conduct on-site and remote monitoring activities using a risk-based monitoring approach, including centralized data review through clinical trial systems
• Ensure enrolment of eligible subjects only and review regulatory documentation for completeness and accuracy
• Oversee investigational product and/or medical device accountability and inventory
• Review adverse events, serious adverse events, and concomitant medications to ensure accurate and timely reporting
• Evaluate site performance related to patient recruitment and retention and provide recommendations for improvement
• Prepare high-quality monitoring reports and follow-up letters, clearly documenting findings, risks, and required actions

Candidate Profile

• Minimum of 1 year of experience as a Clinical Research Associate within a CRO or pharmaceutical environment
• Bachelor’s degree in a health- or science-related discipline
• Strong understanding of ICH-GCP and J-GCP requirements
• Native-level Japanese (JLPT N1)
• Business-level English proficiency (minimum TOEIC score of ~500 or equivalent)
• Willingness to travel approximately 60-80% per month across Japan
• Proficient in Microsoft Office and clinical trial systems
• Strong communication, presentation, and stakeholder-management skills
• Highly detail-oriented with strong organisational and time-management abilities