Clinical Trial Coordinator

• 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

• 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

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