Clinical Trial Coordinator (CTC) - REMOTE
About the position
Responsibilities
• Track essential documents and report safety reports
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Manage clinical and non-clinical supply management in collaboration with other country roles
• Coordinate labeling requirements and translation change requests
• Prepare and manage clinical documents and correspondence
• Assist with eTMF reconciliation and execute eTMF Quality Control Plan
• Update manuals and documents such as patient diaries and instructions
• Document proper destruction of clinical supplies
• Collaborate with country roles for site evaluation and validation
• Obtain and track study insurance certificates
• Support preparation of submission packages for IRB/ERC and regulatory agencies
• Publish study results as required by local legislation
Requirements
• Fluent in local languages and business proficient in English (verbal and written)
• Good understanding of Global, Country/Regional Clinical Research Guidelines
• Hands-on knowledge of Good Documentation Practices
• Strong IT skills, including MS Office and clinical IT applications
• Strong MS Excel skills
• Knowledge of ICH-GCP appropriate to role
• Excellent negotiation skills in finance area
• Effective time management and organizational skills
• Ability to handle multiple tasks in a changing environment
• Ability to establish and maintain culturally sensitive working relationships
• Proactive attitude to problem-solving
Nice-to-haves
• Bachelor's Degree preferred
Benefits
• Flexible work arrangements (remote)
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