Clinical Trial Coordinator

• Provide comprehensive trial and site administration under line-manager oversight
• Prepare, collate, distribute, and archive clinical documents
• Support clinical and non-clinical supply management
• Maintain tracking and reporting tools, clinical trial databases, and CTMS
• Assist with meeting planned Site Ready dates
• Assist with IRB/ERC and Health Authority submission packages
• Collaborate with COM, CRM, CRA, finance, and budgeting representatives
• Manage labeling requirements and coordinate translation change requests
• Prepare, distribute, archive, and quality-control eTMF documents
• Assist with eTMF reconciliation and execute the eTMF Quality Control Plan
• Update manuals and documents, including patient diaries and instructions
• Prepare Investigator trial file binders and obtain document translations
• Obtain, track, and update study insurance certificates
• Publish study results where required by local legislation
• Develop, control, update, and close out country and site budgets
• Develop, negotiate, approve, and maintain CTRAs and contract templates
• Track contract negotiations and calculate and execute payments
• Ensure adherence to financial and compliance procedures
• Monitor disclosures and process FCPA documentation
• Organize meetings and prepare study memos, letters, and protocols
• Support local investigator meetings and associated vendors
• Act as process Subject Matter Expert, share best practices, recommend improvements, and provide training
• Mentor and buddy junior CTCs

Explore Senior Clinical Trial Coordinator at MSD. Review requirements and application details.