Clinical Trial Coordinator

🕒 4 days ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Trial Coordinator

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Provide administrative and technical support to the Project Team • Support audit readiness through scheduled file reviews according to SOPs and department guidance • Provide administrative support for site activation activities and help develop site activation critical paths • Develop and review site lists for feasibility activities and contribute local input to site tiering • Coordinate, oversee and complete assigned trial activities according to the task matrix • Perform department, internal, country and investigator file reviews and document findings • Ensure assigned tasks are completed on time, within budget and to quality standards • Provide system support for Activate and eTMF and keep databases current • Process documents for client eTMF, perform eTMF reviews, distribute communications and provide reports • Analyze and reconcile study metrics and findings reports • Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical supplies • Support translation materials and translation quality control • Conduct on-site feasibility visits where applicable in Asia Pacific • Schedule client and internal meetings as needed • Review and track local regulatory documents • Support risk-based monitoring activities • Maintain study documentation, team lists, training requirements, system access and activity plans • Transmit documents to the client and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and prepare regulatory compliance review packages • Work directly with sites to obtain site-selection documents • Coordinate with internal departments to align site start-up activities with the activation critical path • Complete Site Interest Plans in CTMS and collect associated investigator and site personnel documents • Document communications, follow-ups and survey responses in real time • Review survey data for logical, complete and relevant responses • Collaborate with teammates and clinical personnel regarding site issues and risks • Maintain site contact and follow-up plans and escalate concerns or non-compliance • Act as local expert on site capacity and experience and recommend additional sites • Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information • Contribute to global feasibility processes and best practices • Train new personnel in processes and systems • Use local knowledge to identify and develop new sites

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • Previous experience comparable to 0 to 1 year • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Ability to work in a team or independently • Good organizational skills and strong attention to detail • Ability to handle multiple tasks efficiently and effectively • Ability to analyze project-specific data/systems accurately • Strong customer focus • Flexibility to reprioritize workload • Working knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs • Good English language and grammar skills and proficient local language skills as needed • Proficient in MS Office (Word, Excel, and PowerPoint) • Ability to learn and master clinical trial database systems • Ability to successfully complete the organization's clinical training program • Effective oral and written communication skills • Essential judgment and decision-making skills • Ability to follow project work instructions accurately • Good negotiation skills • Ability to manage risk and perform risk escalation appropriately

🏖️ Benefits

• Fully Remote work arrangement • Full-time employment • Standard Monday–Friday work schedule • Potential occasional travel • Clinical training program • Opportunity to act as a buddy during onboarding and provide training to new staff

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