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CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services
1.001 – 5.000 Angajați
Asistență medicalăBiotehnologieConsultanță
CTI Clinical Trial and Consulting Services este o organizație de cercetare contractuală care deservește sponsori din domeniul biotehnologiei și industriei farmaceutice pe parcursul întregului proces de dezvoltare clinică. Activitatea sa include desfășurarea studiilor clinice, strategia de reglementare, servicii de laborator și bioanalitice, dovezi din lumea reală și gestionarea centrelor de cercetare în studii de fază I–IV. CTI are experiență în domenii precum bolile rare, terapiile celulare și genice, oncologia, neurologia și transplantul, oferind sprijin pentru proiectarea studiilor, gestionarea centrelor, recrutarea pacienților, monitorizare, siguranță și farmacovigilență, biostatistică și asigurarea calității. Compania combină serviciile integrate pentru studii clinice cu cercetarea centrată pe pacient și îndrumarea globală în materie de reglementare.
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Locurile de muncă ale companiei

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.

JPJaponiaRemoteNormă întreagăJuniorNivel mediuLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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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