Senior Clinical Research Associate (SCRA)

The Opportunity

A global clinical research organisation is looking for an experienced Senior Clinical Research Associate (SCRA) to join its growing clinical operations team in South Korea.

This position will take responsibility for the monitoring and management of assigned clinical trial sites, working closely with investigators, study teams and cross-functional stakeholders to ensure studies are delivered to a high standard and in accordance with applicable regulatory and GCP requirements.

The position offers exposure across multiple phases of clinical development and complex therapeutic areas within an established international clinical research environment.

Key Responsibilities

• Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP
• Conduct or assist with study start-up activities, including feasibility, pre-study activities and site selection
• Collect, review and track essential/regulatory documents
• Participate in and complete all general and study specific training as required
• Participate in investigator, client and project team meetings; may include presentations
• Create and implement subject enrollment strategies for assigned study sites
• Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
• Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
• Conduct onsite / remote monitoring and complete related activities in accordance with study specific Monitoring Plan
• Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
• Assist with project-specific activities as member of Project Team

Candidate Profile

• Approximately 2–5+ years of clinical research experience as a CRA or in a closely related clinical monitoring role in South Korea.
• Previous independent site monitoring experience.
• Life sciences, healthcare or another relevant scientific background.
• Strong knowledge of KGCP, ICH-GCP and applicable South Korean clinical trial regulations.
• Experience working across clinical trials from Phase I through Phase IV is advantageous.
• Experience within oncology, rare disease, transplant or other complex therapeutic areas would be beneficial.
• Strong site management, organisation and stakeholder communication skills.
• Comfortable managing multiple studies, protocols and sites.
• Willing and able to undertake nationwide travel within South Korea.
• Excellent written and spoken Korean and English communication skills.
• Must already have full eligibility to work in South Korea. Sponsorship is not available for this position.