Clinical Research Associate II

Join a Global CRO Advancing Innovative Therapies

Our client is a well-established global Contract Research Organisation (CRO) with a strong presence in oncology, rare diseases, cell & gene therapy, and other complex therapeutic areas. Partnering with leading biotech and pharmaceutical companies worldwide, they support the delivery of cutting-edge clinical trials that help bring innovative treatments to patients faster.

This is an excellent opportunity to join a collaborative, international team and gain exposure to challenging, high-impact studies.

Key Responsibilities

• Act as the primary contact for assigned investigative sites.
• Conduct site monitoring visits, including: Pre-Study Visits (PSV)
• Site Initiation Visits (SIV)
• Interim Monitoring Visits (IMV)
• Close-Out Visits (COV)
• Perform site management activities and provide regular updates to the Clinical Project Manager.
• Support study start-up activities, including feasibility assessments and site selection.
• Collect, review, and maintain essential and regulatory documentation.
• Develop and implement subject recruitment and enrolment strategies.
• Conduct on-site and remote monitoring in line with study-specific Monitoring Plans.
• Ensure proper management, storage, accountability, and reconciliation of Investigational Product (IP).
• Review source documentation, perform Source Data Verification (SDV), and oversee CRF completion.
• Participate in investigator meetings, sponsor meetings, and project team discussions.
• Complete all required study-specific and company training.
• Support additional project-related activities as required.

Requirements

• 2-5 years of clinical research experience as a CRA or within a related clinical research role in South Korea.
• Degree in Life Sciences or a related field.
• Strong knowledge of KGCP, ICH-GCP, and applicable regulatory requirements.
• Previous experience in Oncology or Transplant studies is preferred.
• Fluent Korean and English communication skills (written and spoken).
• Strong organisational, communication, and site management skills.
• Full right to work in South Korea. Sponsorship is not available for this position.

What's on Offer?

• Opportunity to work on innovative global clinical trials.
• Exposure to leading biotech and pharmaceutical sponsors.
• Collaborative and supportive international environment.
• Strong focus on professional development and career growth.
• Home-based flexibility with regional travel to investigative sites.