Hybrid Clinical Research Associate II

at Fortrea

• Job title: Clinical Research Associate II
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Tokyo, Japan

About the role

• Clinical Research Associate overseeing clinical studies and ensuring compliance with Fortrea’s SOPs and regulatory standards. Involves site management, monitoring, and data integrity assurance.

Responsibilities

• Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements.
• Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
• Prepares and implements project plans related to Clinical Monitoring responsibilities.
• Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
• Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
• Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
• Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
• Ensures adherence to global quality control and CRA performance metrics.
• Ensures audit readiness at site level.

Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
• A minimum of 2 years of Clinical Monitoring experience.
• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
• Thorough knowledge of monitoring procedures.
• Basic understanding of the clinical trial process.
• Fluent in local office language and in English, both written and verbal.
• Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
• Ability to work with minimal supervision.
• Understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow-up of SAEs.
• Good planning, organization, and problem-solving abilities.

Benefits

• Competitive salary
• Flexible working hours
• Professional development
• Remote work options