Clinical Research Associate

Clinical Research Associate (CRA) – Clinical Trials

Location: Chiyoda-ku, Tokyo, Japan

Industry: Pharmaceuticals | Biotechnology | Clinical Research

Work Arrangement: Site monitoring and travel required; office working arrangement not specified

About the Role

An opportunity is available for a Clinical Research Associate (CRA) to oversee clinical trial activities and ensure studies are conducted in accordance with protocols, Standard Operating Procedures (SOPs), ICH-GCP guidelines, and applicable Japanese regulations.

The position involves clinical site monitoring, investigator engagement, regulatory compliance, and maintaining high standards of patient safety and clinical data quality.

Key Responsibilities

• Conduct site feasibility assessments, site selection, and investigator evaluations.
• Perform site initiation, monitoring, and close-out visits.
• Monitor clinical trial activities to ensure compliance with ICH-GCP, SOPs, protocols, and regulatory requirements.
• Review clinical data, documentation, and electronic case report forms (eCRFs).
• Identify and resolve site issues, deviations, and compliance risks.
• Support corrective and preventive actions (CAPA) and audit readiness.
• Train and support investigators and clinical site personnel.
• Monitor patient enrolment, retention, and study milestones.
• Maintain accurate monitoring reports and trial documentation.
• Collaborate with Clinical Trial Managers and internal and external stakeholders.
• Manage multiple clinical trial protocols and therapeutic areas as assigned.
• Travel to clinical trial sites as required.

Required Qualifications & Experience

• Bachelor's degree, preferably in Life Sciences, or equivalent qualification.
• Experience in clinical research, clinical trial monitoring, or related activities.
• Knowledge of ICH-GCP guidelines and Japanese clinical trial regulations.
• Understanding of clinical research processes, regulatory requirements, and medical records.
• Experience using CTMS, Electronic Data Capture (EDC), and electronic Trial Master File (eTMF) systems.
• Strong organisational, documentation, and stakeholder management skills.
• Proficiency in Microsoft Office.
• Strong written and verbal communication skills in Japanese and English, including business-level English.
• Ability to travel according to clinical trial monitoring requirements.

Experience Levels

• Associate CRA: At least 1 year of relevant clinical research experience and/or education.
• CRA: 2–3 years of relevant clinical research experience, with the ability to work independently.
• Senior CRA: At least 5 years of clinical monitoring experience, with leadership, coaching, and mentoring capabilities.

Preferred Experience

• Previous experience with a pharmaceutical or biotechnology sponsor.
• Experience as a Clinical Study Coordinator.
• Knowledge of drug discovery and development processes.

Additional Information

• Location: Tokyo, Japan.
• Clinical site travel is required.
• Competitive benefits are referenced, but salary and specific benefits are not disclosed.
• Applications submitted through recruitment agencies are not accepted for this position.