Clinical Research Associate

🔥 2 hours ago

🇯🇵 Japan – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Manage project activities associated with monitoring functions of Phase I through Phase IV clinical research studies and Real World Evidence studies • Serve as the main CTI contact for assigned study sites • Conduct pre-study, site initiation, interim monitoring, and close-out visits and complete visit deliverables • Assist with study start-up, feasibility, pre-study activities, and site selection • Collect, review, and track essential and regulatory documents • Complete general and study-specific training • Participate in investigator, client, and project team meetings • Create and implement subject enrollment strategies • Ensure proper storage, dispensation, and accountability of investigational product and trial-related materials • Provide ongoing site status updates to the Clinical Project Manager • Conduct remote monitoring according to study-specific monitoring plans • Track subject status, CRF retrieval/source document review, regulatory documents, and investigational product using systems and reports • Support project-specific activities as a member of the Project Team • Support development, translation, customization, and review of study-related documents • Support regulatory submission documentation and follow-up where applicable • Provide regular updates to the Sponsor/Client • Support site contract negotiation, investigator payments, and site payment tracking where applicable • Manage ISF and TMF for assigned study sites • Identify site issues, implement corrective actions, or escalate as appropriate • Liaise with Clinical Data Management for data cleaning activities • Assist in preparing and coordinating investigator and client meetings

🎯 Requirements

• At least 1 year of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources • Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health / natural science; or RN with Associate's Degree; or 3-year Nursing Diploma with at least 2 years of clinical nursing experience; or equivalent experience as determined by CTI Management and Human Resources • Previous experience conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO • Knowledge of the drug development process, ICH/GCP, and relevant regulations • Ability to perform site management activities in adherence to regulatory guidelines and SOPs

🏖️ Benefits

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