Senior Clinical Research Associate – Japan

This is a fully remote position, open to applicants in Japan.

📋 Description

• Lead the processes of site qualification, initiation, interim monitoring, management, and close-out visits.

• Supervise site performance through source document verification, CRF and EDC review, resolution of data queries, adherence to protocols, review of informed consent, and ongoing assessment of patient safety.

• Collaborate with investigative sites to ensure maintenance of essential documentation, regulatory and ethical submissions, Investigator Site Files, Trial Master File documentation, and accountability for investigational products.

• Act as a Lead CRA on global studies as assigned.

• Coordinate CRAs, review site visit reports, and assist in meeting study deliverables and milestones in collaboration with Project Management.

• Provide mentorship to less experienced CRAs and site staff through training, guidance, accompanied visits, and practical support.

• Create clinical monitoring plans, study-specific tools, templates, and training materials.

• Work together with study teams and investigators in team meetings, investigator meetings, bid defenses, and the development of protocols and CRFs.

• Sustain effective communication with sites, document monitoring findings, and ensure timely and accurate reporting of data and safety events.

⛳️ Requirements

• An MD or pharmacy-related advanced degree with a minimum of 3 years of CRA experience; or

• 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, combined with at least 7 years of CRA experience.

• Experience in full-service monitoring is preferred.

• Strong comprehension of clinical research principles, GCP, ICH Guidelines, relevant FDA and/or EU regulations and directives, local regulatory requirements, and SOPs.

• Experience in two to three therapeutic areas, with sufficient knowledge to operate as a Lead CRA when applicable.

• Exceptional communication, interpersonal, planning, organizational, time-management, initiative, and problem-solving skills.

• Capability to lead and inspire others when necessary.

• Proficiency in Microsoft Office, IxRS, and EDC systems.

• At least intermediate proficiency in both spoken and written English.

• Proficiency in the local language.

• Readiness to travel.

• A valid current passport and driving license.

🏝️ Benefits

• A collaborative and inclusive work environment.

• Opportunities for growth and career development.

• Learning opportunities available.

• Home-based/remote work arrangement.