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CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services
1,001 – 5,000 Employees
BiotechnologyConsultingHealthcare
CTI Clinical Trial and Consulting Services is a contract research organization serving biotechnology and pharmaceutical sponsors throughout the clinical development process. Its work spans clinical trial execution, regulatory strategy, laboratory and bioanalytical services, real-world evidence, and research center management across Phase I–IV studies. CTI brings experience in areas such as rare diseases, cell and gene therapy, oncology, neurology, and transplantation, supporting study design, site management, patient recruitment, monitoring, safety and pharmacovigilance, biometrics, and quality assurance. The company combines integrated trial services with patient-focused research and global regulatory guidance.
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Clinical Research Associate – Japan (Remote)

Monitor Phase I–IV clinical trials and real-world evidence studies for CTI, a global clinical research organization. Manage study sites, regulatory records, investigational products, monitoring visits, and related site activities.

JPJapanRemoteFull-timeJuniorMiddleEnglish RequiredClinical Research
Google Cloud Platform

Description

  • Oversee monitoring activities for Phase I–IV clinical trials and real-world evidence studies
  • Act as CTI’s primary contact for assigned study sites
  • Conduct pre-study, site initiation, interim monitoring, and close-out visits, including all required deliverables
  • Support study start-up, feasibility assessments, pre-study work, and site selection
  • Collect, review, and maintain essential and regulatory documentation
  • Complete required general and study-specific training
  • Attend investigator, client, and project team meetings
  • Develop and execute subject enrollment strategies
  • Maintain appropriate storage, dispensing, and accountability of investigational products and trial materials
  • Provide regular site status updates to the Clinical Project Manager
  • Perform remote monitoring in line with study-specific monitoring plans
  • Track subject status, CRF retrieval, source document review, regulatory records, and investigational products through systems and reports
  • Contribute to project-specific work as a member of the Project Team
  • Help develop, translate, customize, and review study documentation
  • Support regulatory submission documents and follow-up activities when applicable
  • Deliver regular updates to the Sponsor or Client
  • Support site contract negotiations, investigator payments, and site payment tracking when applicable
  • Maintain the Investigator Site File and Trial Master File for assigned sites
  • Identify site issues, implement corrective actions, or escalate concerns as appropriate
  • Coordinate with Clinical Data Management on data cleaning activities
  • Help prepare and coordinate investigator and client meetings

Requirements

  • At least one year of clinical trial monitoring experience, or equivalent experience approved by CTI Management and Human Resources
  • Bachelor’s degree or higher in nursing, pharmacy, health science, natural science, or a related allied health field; alternatively, an RN with an associate degree or a three-year nursing diploma with at least two years of clinical nursing experience, subject to CTI equivalency review
  • Prior clinical research experience in a hospital, pharmaceutical company, or contract research organization
  • Working knowledge of drug development, ICH/GCP, and applicable regulations
  • Ability to manage clinical sites in accordance with regulatory requirements and standard operating procedures

Benefits

  • Structured mentoring program
  • Leadership development courses
  • Tuition reimbursement
  • Dedicated training department
  • Comprehensive health benefits
  • Vacation packages
  • Hybrid work-from-home opportunities
  • Paid parental leave
  • CTI Cares program
  • Work-life balance support

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