đ Champion Excellence in Oncology Research: CRA II (Oncology) - Home-Based, South Korea
Join ICON plc, a world-leading healthcare intelligence and clinical research organization, as a Clinical Research Associate II (CRA II) specializing in Oncology. This is a critical home-based, field-monitoring role in South Korea where you will serve as the primary guardian of data integrity, patient safety, and protocol compliance at investigative sites conducting groundbreaking global oncology trials. Your expertise will directly contribute to the development of innovative cancer therapies that offer new hope to patients.
We are seeking an experienced and independent Oncology CRA with proven on-site monitoring experience in global oncology studies. If you are driven by scientific rigor, excel in building collaborative site relationships in a complex therapeutic area, and are passionate about upholding the highest standards in cancer research, this is your opportunity to advance your career with a global industry leader.
đŻ Your Oncology Site Management Mission: Key Responsibilities
End-to-End Oncology Site Oversight
- Conduct the full cycle of oncology-specific site management visits: site qualification, initiation, routine monitoring, and close-out visits, ensuring strict adherence to complex protocols, ICH-GCP, and MFDS regulations.
- Serve as the primary point of contact for assigned oncology investigative sites, building strong, collaborative relationships with oncologists and site staff to facilitate smooth study conduct and patient recruitment.
Oncology Data Integrity & Patient Safety Vigilance
- Perform comprehensive source data verification (SDV) and meticulous review of oncology-specific case report forms (eCRFs/CRFs), including complex tumor response assessments (RECIST) and adverse event reporting.
- Verify the ongoing protection, rights, and well-being of oncology patients, ensuring all site activities adhere to the approved protocol, ethical standards, and stringent safety monitoring plans.
- Proactively identify, document, and resolve site issues, deviations, or non-compliance in a high-stakes therapeutic area, ensuring timely and effective corrective actions.
Documentation Excellence & Regulatory Stewardship
- Contribute to the preparation, review, and finalization of essential oncology study documentation, including protocols, clinical study reports (CSRs), and monitoring visit reports.
- Ensure the complete collection, review, and maintenance of all essential regulatory documents in the Trial Master File (TMF) to maintain constant audit and inspection readiness.
- Support sites with regulatory and safety reporting obligations, including the management of Serious Adverse Event (SAE) reporting in oncology trials.
Collaboration, Training & Communication
- Collaborate effectively with internal cross-functional teams, including Clinical Project Managers, Data Management, and Safety, to ensure aligned study progress and rapid issue resolution.
- Train and support oncology site staff on the study protocol, procedures, GCP, and electronic data capture (EDC) systems.
- Maintain clear, professional, and timely communication with all stakeholders.
â Your Profile: Oncology CRA II Qualifications & Expertise
Essential Requirements
- Bachelorâs degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related healthcare/scientific field.
- Minimum of 2 years of independent, on-site monitoring experience as a Clinical Research Associate (CRA).
- Must have proven, hands-on Site (SIT) monitoring experience in global oncology studies.
- In-depth, practical knowledge of clinical trial processes, ICH-GCP guidelines, and relevant South Korean (MFDS) regulatory requirements.
- Fluency in Korean and professional proficiency in English (written and verbal) is required.
- Ability to travel approximately 60% of the time (domestic within South Korea), possessing a valid driverâs license.
Core Competencies
- Oncology-Specific Site Management Skills:Â Demonstrated expertise in managing oncology sites, understanding oncology endpoints, and handling complex data.
- Analytical & Detail-Oriented:Â Strong analytical skills with an unwavering focus on data quality and meticulous attention to detail in a high-complexity therapeutic area.
- Regulatory Acumen:Â Solid understanding of clinical trial documentation standards and regulatory compliance in South Korea.
- Technical Proficiency:Â Hands-on experience with clinical technology systems (CTMS, EDC, eTMF).
Professional Attributes
- Excellent Organizational Skills:Â Ability to independently manage multiple oncology sites, priorities, and deliverables in a fast-paced environment.
- Superior Communication & Interpersonal Skills:Â Ability to build trust, influence, negotiate, and resolve issues effectively with investigators and site staff.
- Proactive Problem-Solver:Â Self-motivated, resourceful, and capable of anticipating risks and implementing practical solutions in oncology trials.
- Collaborative Team Player:Â Works effectively as part of both local and global virtual teams.
đŤ Why Build Your Oncology Monitoring Career at ICON in South Korea?
Impact Pioneering Cancer Research
- Play a direct, hands-on role in executing cutting-edge global oncology clinical trials that bring new therapies to cancer patients in South Korea.
- Ensure the highest standards of ethical conduct and data quality, which are foundational to successful regulatory submissions and approvals in oncology.
Career Growth & Therapeutic Specialization
- Clear career progression pathway to Senior CRA, Lead CRA, and Clinical Team Lead roles within a leading oncology-focused CRO.
- Deepen your therapeutic expertise in oncology, one of the most dynamic and critical areas of clinical development.
- Continuous professional development through structured global and local training programs and mentorship.
Home-Based Flexibility with Global Support
- #LI-Remote:Â Maximize your productivity and work-life balance with a home-based role while conducting essential field monitoring across South Korea.
- Receive comprehensive support from dedicated line management, robust internal processes, and a collaborative international team.
- Join a diverse and dynamic team where inclusion, belonging, and innovation are core to our values.
Competitive ICON Benefits in South Korea
- Attractive salary and performance-based bonus incentives.
- Comprehensive benefits package including health, dental, and life insurance.
- Generous annual leave entitlements.
- Competitive retirement planning offerings.
- Global Employee Assistance Programme (EAP) providing 24/7 confidential support for you and your family.
- Car allowance and home-based office setup support.
- Ongoing investment in your career growth through training and development allowances.
â¨Â Ready to Ensure Excellence at Oncology Clinical Sites in South Korea?
If you are a dedicated, travel-ready Oncology CRA with a passion for upholding the highest standards in cancer research, we encourage you to apply. This CRA II role offers a unique home-based opportunity to be at the forefront of oncology development, ensuring the integrity of trials that transform patient care.
Apply Now and become ICON's next key expert in oncology clinical trial monitoring in South Korea.
