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About the Role
The Clinical Research Coordinator is responsible for coordinating and managing in-house clinical research for the GE HealthCare Ultrasound business in Japan, working under the direction of the Global Research Team and closely with local stakeholders.
Responsibilities
- Recruit, screen, enroll, and obtain informed consent from study participants.
- Coordinate and oversee research sessions, including scheduling participants, reserving space, ensuring staff training, and managing documentation.
- Ensure compliance with the study protocol, applicable regulations, GCP and IRB requirements, and internal GE HealthCare processes.
- Maintain study documentation, including regulatory binders, source documentation, trackers, training records, delegation records, and other study materials.
- Complete and coordinate IRB submissions and correspondence, including new submissions, continuing review or renewal, amendments, deviation reports, adverse event reports, and other required notifications.
- Conduct training and provide guidance to study staff.
- Facilitate monitoring visits, respond to document requests and follow-up actions, and prepare for audits as needed.
- Serve as the main operational point of contact for research volunteers and study staff.
- Maintain research facilities, including the consent area and scan bays; order supplies and track spend.
- Implement process improvements and electronic processes to facilitate compliance, traceability, data integrity, and efficiency.
- Provide support to Research Program Integrators and other study stakeholders as needed.
- Serve as a Subject Matter Expert for coordinators at global sites executing similar protocols.
- Coordinate routinely with the Global Research Team through written communication and virtual meetings; communicate study status, issues and risks; and follow up on agreed actions.
- Identify and promptly escalate protocol deviations, participant concerns, documentation gaps, data-quality issues, and other study risks to the PI and appropriate global study stakeholders.
- Support limited protocol-driven ultrasound data collection, subject to study needs, restrictions, training, qualification, and delegation.
Requirements
- Bachelor’s degree in science, healthcare, engineering, a research-related field, or equivalent relevant experience.
- Minimum of two years of experience in clinical research or closely related research operations.
- Outstanding organizational skills and meticulous attention to detail.
- Proficiency with Microsoft Office applications, including Excel, Outlook, and Word.
- Excellent Japanese communication skills for interaction with research volunteers and local study staff.
- Strong business English skills, written and verbal, sufficient to communicate independently with the Global Research Team.
- Ability to manage multiple studies, participant schedules, documentation deliverables, and competing priorities with limited supervision.
- Ability and willingness to work on-site during scheduled volunteer research and ultrasound scanning sessions.
Skills
- Clinical research
- Research operations
- Organizational skills
- Attention to detail
- Microsoft Office Suite (Excel, Outlook, Word)
- Japanese communication
- Business English communication
- Project management
- GCP
- IRB submissions
- Monitoring
- Audits
- Study-document management
- Cross-functional collaboration
- Relationship building
Location
- Japan
Work Type
- On-site
Experience Level
- Minimum of two years
Education Level
- Bachelor’s degree
Benefits
- Total rewards designed to unlock ambition
- Boost and flexibility
- Salary and benefits expected from an organization with global strength and scale
- Career opportunities
- Culture that fosters care, collaboration and support
About the Company
- GE HealthCare is a leading global medical technology and digital solutions innovator.
- Our purpose is to create a world where healthcare has no limits.
- We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Equal Opportunity
- GE HealthCare is an Equal Opportunity Employer where inclusion matters.
- Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.