Senior Clinical Research Associate – Oncology

🔥 0 minutes ago

🇰🇷 South Korea – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Lead site qualification, initiation, monitoring, management, and close-out activities in accordance with study protocols, GCP, and regulatory requirements • Evaluate site performance and protocol compliance while helping drive high-quality, timely clinical data collection • Serve as a Lead CRA on global studies, coordinating monitoring activities and supporting other CRAs as needed • Review source documentation, informed consent processes, safety information, and case report forms to ensure data integrity and patient safety • Mentor and train site personnel and less experienced CRAs on study requirements, monitoring practices, and protocol adherence • Partner with Project Management and study teams to track study milestones, evaluate deliverables, and support successful study execution • Prepare and review monitoring reports, regulatory documentation, and essential study records, ensuring accurate Trial Master File maintenance • Support investigator meetings, study team training, bid defenses, and the development of study-specific tools, plans, and templates • Maintain strong communication with investigative sites and provide ongoing guidance to facilitate efficient study conduct and query resolution • Support sites across South Korea and travel to investigative sites approximately 8–10 days per month

🎯 Requirements

• Medical Doctor (MD) degree or Pharmacy degree with at least 3 years of Clinical Research Associate experience; OR a four-year degree in a medical, biological, health, pharmacy, physical science, or related discipline with at least 5 years of Clinical Research Associate experience; OR a two-year college curriculum/equivalent education (nursing or life science preferred) with at least 7 years of Clinical Research Associate experience • Extensive knowledge of clinical research processes, monitoring practices, and site management activities • Strong understanding of FDA and/or EU regulations, ICH Guidelines, GCP, local regulatory requirements, and clinical trial SOPs • Demonstrated experience across multiple therapeutic areas with the ability to function as a Lead CRA • Experience using Microsoft Office, electronic data capture (EDC) systems, and IxRS platforms • Excellent communication, organization, time management, problem-solving, and interpersonal skills • Proficiency in English and fluency in local language(s) required for countries under responsibility • Experience in full-service monitoring PREFERRED

🏖️ Benefits

• Home-based work arrangement • Opportunity to learn and grow • Leadership, mentorship, and strategic input opportunities • Collaborative and inclusive work environment • Professional development through mentoring and training opportunities

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