Clinical Trial Coordinator

🔥 0 minutes ago

🇻🇳 Vietnam – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Trial Coordinator

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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

• Coordinate and administer clinical studies from start-up to execution and close-out • Collect, prepare, review, track, submit, upload, maintain, and archive clinical-regulatory documents • Support Ethics Committee/Institutional Review Board and Regulatory Authority applications and submissions • Serve as the local administrative main contact and collaborate with CRAs, LSADs, Investigators, external service providers, vendors, and internal teams • Set up and maintain local eTMF and ISF in accordance with ICH-GCP and local requirements • Create and import clinical-regulatory documents into the Global Electronic Management System • Support electronic submissions according to Submission Ready Standards • Set up and maintain client tracking and communication tools such as CTMS and SharePoint • Prepare or support site-level contracts and HCO/HCP payments • Coordinate study materials, equipment, audits, regulatory inspections, meetings, presentations, newsletters, websites, translations, and document distribution • Facilitate delivery of study-related documents and materials with Data Management and Global Clinical Solutions representatives • Ensure compliance with applicable ethics, company, safety, health, environmental, and legal requirements

🎯 Requirements

• Experience level may determine internal title (CTC or Senior CTC) • Ability to coordinate and administer clinical studies from start-up through execution and close-out • Knowledge of ICH-GCP and local requirements • Ability to prepare, review, track, upload, maintain, and archive essential clinical-trial documents • Ability to submit documents to Ethics Committees/Institutional Review Boards and, where appropriate, Regulatory Authorities • Experience or ability to work with Investigators, external service providers, CRAs, LSADs, Data Management, and vendors • Ability to use electronic trial systems including eTMF, ISF, CTMS, SharePoint, and electronic management systems such as ANGEL • Ability to prepare or support site-level contracts and HCO/HCP payments in accordance with local regulations • Ability to coordinate study materials and equipment • Ability to support audits, regulatory inspections, meetings, presentations, newsletters, websites, translations, and document distribution • Compliance with client Code of Ethics, company policies and procedures, and applicable local, national, and regional legislation

🏖️ Benefits

• Fully Remote work arrangement • Standard Monday–Friday work schedule

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