Senior Clinical Research Associate – Onco

🔥 1 minute ago

🇹🇼 Taiwan – 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, and close-out activities in accordance with protocols, GCP, SOPs, and applicable regulations • Build relationships with investigative sites and provide ongoing support for study quality, compliance, and timely data submission • Review source documentation, study data, safety reporting, and informed consent processes • Coordinate and maintain regulatory and ethics documentation and ensure inspection readiness • Collaborate with project teams to track study milestones, resolve operational challenges, and support study delivery • Mentor and guide less experienced CRAs and site personnel • Contribute to clinical monitoring plans, study tools, training programs, investigator meetings, and bid defense activities • Evaluate investigational product accountability, site compliance, and operational processes • Document findings through clear and accurate reports • Partner with sites, sponsors, and global study teams throughout the clinical trial lifecycle

🎯 Requirements

• MD, Pharmacy degree (MSPH, PharmD, PhD, or equivalent) plus a minimum of 3 years of Clinical Research Associate experience; OR a four-year degree in a medical, biological, physical, health, pharmacy, or related science field plus 5 years of CRA experience; OR a two-year college curriculum/equivalent training (nursing or life sciences preferred) plus 7 years of CRA experience • Extensive experience in clinical research monitoring and site management across the clinical trial lifecycle • Thorough knowledge of ICH-GCP, FDA and/or EU regulations, local regulatory requirements, and clinical research processes • Strong understanding of at least two to three therapeutic areas with the ability to function as a Lead CRA • Experience using EDC systems, IxRS platforms, and Microsoft Office applications • Excellent communication, organizational, time management, problem-solving, and interpersonal skills • Proficiency in English and fluency in the local language(s) of the countries under responsibility, both written and spoken • Full-service monitoring experience preferred • Must reside in Taiwan • Ability to travel to investigative sites approximately 8-10 days per month • Willingness to travel regionally and occasionally to other locations as needed

🏖️ Benefits

• Home-based work arrangement • Opportunity to learn and grow • Collaborative and inclusive work environment • Mentoring and professional development opportunities • Global team collaboration • Meaningful work supporting life-changing therapies

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