Clinical Research Associate

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

📋 Description

• Oversee project activities related to the monitoring functions of Phase I to Phase IV clinical research studies and Real World Evidence studies.

• Act as the primary CTI liaison for designated study sites.

• Perform pre-study assessments, site initiation, interim monitoring, and close-out visits, ensuring all visit deliverables are completed.

• Aid in study initiation, feasibility assessments, pre-study tasks, and site selection processes.

• Gather, review, and maintain essential and regulatory documentation.

• Complete both general and study-specific training requirements.

• Engage in meetings with investigators, clients, and project teams.

• Develop and execute strategies for subject enrollment.

• Guarantee proper storage, distribution, and accountability of investigational products and trial-related materials.

• Provide continuous site status updates to the Clinical Project Manager.

• Conduct remote monitoring in accordance with study-specific monitoring plans.

• Monitor subject status, CRF retrieval/source document review, regulatory documents, and investigational product through various systems and reports.

• Assist in project-specific activities as part of the Project Team.

• Aid in the development, translation, customization, and review of study-related documents.

• Support regulatory submission documentation and any necessary follow-up.

• Deliver regular updates to the Sponsor/Client.

• Assist in site contract negotiations, investigator payments, and tracking site payments where applicable.

• Manage the ISF and TMF for the assigned study sites.

• Identify site-related issues, execute corrective actions, or escalate as needed.

• Collaborate with Clinical Data Management for data cleaning initiatives.

• Assist in organizing and coordinating investigator and client meetings.

⛳️ Requirements

• Minimum of 1 year of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources.

• Bachelor’s Degree or higher in a relevant health field such as nursing, pharmacy, or health/natural sciences; or RN with an Associate's Degree; or a 3-year Nursing Diploma accompanied by at least 2 years of clinical nursing experience; or equivalent experience as determined by CTI Management and Human Resources.

• Prior experience in conducting clinical research studies within a hospital, pharmaceutical company, or CRO setting.

• Familiarity with the drug development process, ICH/GCP, and pertinent regulations.

• Capability to execute site management activities in accordance with regulatory guidelines and SOPs.

🏝️ Benefits

• Structured mentoring program.

• Leadership courses.

• Tuition reimbursement.

• Dedicated training department.

• Comprehensive health benefits.

• Vacation packages.

• Hybrid work-from-home opportunities.

• Paid parental leave.

• CTI Cares program.

• Support for work-life balance.