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

• Act as the primary point of contact for assigned clinical trial sites.
• Conduct site visits including pre-study, site initiation, interim monitoring and close-out visits.
• Complete monitoring activities and associated documentation accurately and within agreed timelines.
• Conduct both onsite and remote monitoring in accordance with study-specific monitoring plans.
• Support study start-up activities, including feasibility assessments, site identification and site selection.
• Collect, review and track essential and regulatory documentation.
• Ensure compliance with applicable SOPs, regulatory requirements, KGCP and ICH-GCP.
• Monitor subject recruitment and support sites with enrolment strategies where required.
• Ensure appropriate storage, dispensing and accountability of investigational products and trial-related materials.
• Perform ongoing site management and provide regular updates on site performance and study progress.
• Track subject status, CRF completion, source data verification, regulatory documentation and investigational product accountability.
• Participate in investigator meetings, project team meetings and client meetings as required.
• Work closely with Clinical Project Managers and wider study teams to identify and resolve site-level issues.
• Complete all required general and study-specific training.
• Support additional project activities as a member of the wider clinical study 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.

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

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