Senior Clinical Research Associate – Japan

🔥 1 minute ago

🇯🇵 Japan – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Lead site qualification, initiation, interim monitoring, management, and close-out visits • Oversee site performance through source document verification, CRF and EDC review, data query resolution, protocol adherence, informed consent review, and ongoing patient-safety assessment • Partner with investigative sites to maintain essential documentation, regulatory and ethics submissions, Investigator Site Files, Trial Master File documentation, and investigational product accountability • Serve as a Lead CRA on global studies when assigned • Coordinate CRAs, review site visit reports, and support study deliverables and milestones with Project Management • Mentor less experienced CRAs and site staff through training, guidance, accompanied visits, and practical support • Develop clinical monitoring plans, study-specific tools, templates, and training materials • Collaborate with study teams and investigators in team meetings, investigator meetings, bid defenses, and protocol and CRF development • Maintain effective communication with sites, document monitoring findings, and support timely, accurate data and safety-event reporting

🎯 Requirements

• MD or pharmacy-related advanced degree plus at least 3 years of CRA experience; or • Four-year degree in a medical, biological, physical, health, pharmacy, or related science plus at least 5 years of CRA experience; or • Two-year college curriculum or equivalent education/training, preferably in nursing or life sciences, plus at least 7 years of CRA experience • Experience in full-service monitoring preferred • Strong understanding of clinical research principles, GCP, ICH Guidelines, applicable FDA and/or EU regulations and directives, local regulatory requirements, and SOPs • Experience across two to three therapeutic areas, with depth of knowledge to function as a Lead CRA where appropriate • Excellent communication, interpersonal, planning, organizational, time-management, initiative, and problem-solving skills • Ability to lead and motivate others where applicable • Proficiency with Microsoft Office, IxRS, and EDC systems • At least intermediate proficiency in spoken and written English • Proficiency in the local language • Willingness to travel • Valid current passport and driving license

🏖️ Benefits

• Collaborative and inclusive work environment • Growth and career development opportunities • Learning opportunities • Home-based/remote work arrangement

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