Clinical Trial Coordinator

This is a fully remote position, open to applicants in Vietnam.

📋 Description

• Oversee and manage clinical studies from initiation through execution and final closure.

• Gather, prepare, review, monitor, submit, upload, maintain, and archive clinical-regulatory documentation.

• Assist with the application and submission processes for Ethics Committee/Institutional Review Board and Regulatory Authority.

• Act as the primary local administrative contact and collaborate with CRAs, LSADs, investigators, external service providers, vendors, and internal teams.

• Establish and maintain local eTMF and ISF in compliance with ICH-GCP and local regulations.

• Create and import clinical-regulatory documents into the Global Electronic Management System.

• Provide support for electronic submissions following Submission Ready Standards.

• Develop and maintain client tracking and communication tools such as CTMS and SharePoint.

• Prepare or assist with site-level contracts and HCO/HCP payments.

• Organize study materials, equipment, audits, regulatory inspections, meetings, presentations, newsletters, websites, translations, and document distribution.

• Facilitate the delivery of study-related documents and materials in coordination with Data Management and Global Clinical Solutions representatives.

• Ensure adherence to applicable ethics, corporate, safety, health, environmental, and legal standards.

⛳️ Requirements

• Experience level may influence internal title (CTC or Senior CTC).

• Capability to coordinate and manage clinical studies from initiation to execution and closure.

• Proficiency in ICH-GCP and local regulations.

• Skill in preparing, reviewing, tracking, uploading, maintaining, and archiving critical clinical-trial documents.

• Competence in submitting documents to Ethics Committees/Institutional Review Boards and, when applicable, Regulatory Authorities.

• Experience or ability to collaborate with investigators, external service providers, CRAs, LSADs, Data Management, and vendors.

• Proficiency in utilizing electronic trial systems including eTMF, ISF, CTMS, SharePoint, and electronic management systems such as ANGEL.

• Ability to prepare or assist with site-level contracts and HCO/HCP payments in compliance with local laws.

• Competence in coordinating study materials and equipment.

• Ability to support audits, regulatory inspections, meetings, presentations, newsletters, websites, translations, and document distribution.

• Commitment to compliance with the client Code of Ethics, corporate policies and procedures, and relevant local, national, and regional laws.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.