Senior Clinical Research Associate (Japan)

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. 

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. 

As a Senior Clinical Research Associate, you’ll play a key role in protecting patient safety, ensuring high-quality clinical data, and supporting successful study delivery across Japan. You’ll take ownership of site qualification, initiation, monitoring, management, and close-out activities, ensuring studies are conducted in line with GCP, applicable regulations, and study requirements.

You’ll bring your monitoring expertise to complex studies while partnering closely with investigative sites, Project Management, and global study teams. Depending on the study, you may also serve as a Lead CRA, coordinate and mentor other CRAs, contribute to monitoring plans and study tools, and help teams achieve key study milestones.

This is an opportunity to combine independent site management with broader study-level impact, using your experience to strengthen site performance, data quality, compliance, and patient safety throughout the clinical trial lifecycle.

This is a home-based Clinical Research Associate role supporting sites across Japan. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams.

To best support our sites, we're seeking candidates who are based in Japan.

• →Lead site qualification, initiation, interim monitoring, management, and close-out visits in accordance with study requirements, GCP, applicable regulations, and SOPs.
• →Oversee site performance through source document verification, CRF and EDC review, data query resolution, protocol adherence, informed consent review, and ongoing assessment of patient safety.
• →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, coordinating CRAs, reviewing site visit reports, and working with Project Management to support study deliverables and milestones.
• →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 as requested to support effective study delivery.
• →Collaborate with study teams and investigators, contributing to team meetings, investigator meetings, bid defenses, and the development of protocols and CRFs.
• →Maintain effective communication with sites, documenting monitoring findings and supporting timely, accurate data and safety-event reporting.

• Education and CRA experience: an MD or pharmacy-related advanced degree with at least 3 years of CRA experience; a four-year degree in a medical, biological, physical, health, pharmacy, or related science with at least 5 years of CRA experience; or a two-year college curriculum or equivalent education/training, preferably in nursing or life sciences, with 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 the depth of knowledge required to function as a Lead CRA where appropriate.
• Excellent communication, interpersonal, planning, organizational, time-management, initiative, and problem-solving skills, with the 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, plus proficiency in the local language.
• Willingness to travel, with a valid current passport and driving license.

We love knowing that someone is going to have a better life because of the work we do.  Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.