Clinical Research Coordinator

Job Description Summary

The Clinical Research Coordinator is responsible for coordinating and managing in-house clinical research for the GE HealthCare Ultrasound business in Japan.
The role works under the direction of the Global Research Team and works closely with the local Principal Investigator (PI), Research Program Integrators, study monitors, engineers, clinical specialists, and other study stakeholders.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Essential Responsibilities

Duties include (but are not limited to):

·         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.

·         Ultrasound scanning is not a core responsibility. Depending on study needs, applicable restrictions, documented training and qualification, and formal delegation, the employee may support limited protocol-driven ultrasound data collection.

This role requires physical presence at the designated GE HealthCare facility during volunteer research and ultrasound scanning sessions.

Qualifications / Requirements

1.       Bachelor’s degree in science, healthcare, engineering, a research-related field, or equivalent relevant experience.

2.       Previous experience with a minimum of two years in clinical research or closely related research operations.

3.       Outstanding organizational skills and meticulous attention to detail.

4.       Proficiency with Microsoft Office applications, including Excel, Outlook, and Word.

5.       Excellent Japanese communication skills for interaction with research volunteers and local study staff.

6.       Strong business English skills, written and verbal, sufficient to communicate independently with the Global Research Team in routine virtual meetings and correspondence; explain study status, issues, risks and actions; prepare and review study documentation; and complete English-language GCP and internal procedure training.

7.       Ability to manage multiple studies, participant schedules, documentation deliverables, and competing priorities with limited supervision.

8.       Ability and willingness to work on-site during scheduled volunteer research and ultrasound scanning sessions.

Desired Characteristics

9.       CCRC or CCRP certification preferred.

10.    Previous experience as a Clinical Research Coordinator.

11.    Experience with GCP-governed clinical research, IRB submissions, monitoring, audits, and study-document management.

12.    Experience working in a global or cross-functional research organization.

13.    Healthcare or medical-device experience, particularly in diagnostic ultrasound.

14.    Hands-on ultrasound scanning experience is a plus, but is not required. Any scanning assignment is subject to study-specific restrictions, training, qualification, and delegation.

15.    Ability to build effective working relationships across time zones and functions while maintaining clear ownership and follow-through.

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.

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.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information