Key Responsibilities:
• Conduct site assessments (e.g., phone calls, questionnaires).
• Serve as the primary contact between the site and company.
• Support or manage CA/EC submissions as needed.
• Review and help develop study protocols, CRFs, and validation tools.
• Participate in investigator meetings and assist with preparation.
• Conduct site visits according to SOPs and GCP.
• Ensure sites have the necessary study access and equipment.
• Oversee investigational product accountability and documentation.
• Review and maintain Investigator Site Files (ISF) for accuracy and audit readiness.
Qualifications:
• A degree in life sciences, nursing, pharmacy, medical laboratory technology, or a
related field preferred. Equivalent clinical research experience acceptable.
• Minimum 4 years of monitoring experience or a combination of on-site monitoring
and clinical research experience.
• Fluent / Native Japanese language.
• Experience in Oncology trials is preferred but not essential.