Clinical Trial Coordinator

• Coordinate and administer clinical studies from start-up through execution and close-out
• Collect, prepare, review and track documents for ethics committee/IRB and regulatory submissions
• Interface with investigators, external service providers and CRAs during document collection
• Serve as the local administrative main contact and work closely with CRAs and/or LSAD
• Set up and maintain the local eTMF and ISF in accordance with ICH-GCP and local requirements
• Upload essential documents promptly to maintain eTMF inspection readiness
• Prepare documents for final archiving and support CRA close-out activities for the ISF
• Produce and maintain study documents in compliance with templates and version requirements
• Create/import clinical-regulatory documents into the Global Electronic Management System
• Support electronic applications and submissions using Submission Ready Standards
• Set up and maintain information in CTMS, SharePoint and other tracking/communication tools
• Prepare or support site-level contract preparation
• Prepare, support or perform HCO/HCP payments in accordance with local regulations
• Coordinate and track study materials and equipment
• Coordinate administrative tasks during studies, audits and regulatory inspections
• Lead practical arrangements and support preparation of internal and external meetings
• Liaise with meeting participants and vendors in accordance with international and local codes
• Prepare, contribute to and distribute presentation materials, newsletters and website content
• Perform layout and language control, copying and document distribution
• Support local translation and spell checks between English and the local language
• Print and distribute letters and meeting minutes and handle/archive study-related emails
• Interface with Data Management and Global Clinical Solutions representatives
• Ensure compliance with company ethics, policies, SOPs, legislation and safety requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• Previous experience providing the knowledge, skills, and abilities to perform the job (comparable +2 year)
• An equivalency combining appropriate education, training and/or directly related experience may meet role requirements
• Ability to work independently or in a team
• Good organizational skills and strong attention to detail
• Ability to handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems for accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload according to changing project timelines
• Working knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs
• Good English language and grammar skills and proficient local language skills as needed
• Proficiency in MS Office, including Word, Excel and PowerPoint
• Ability to learn and master clinical trial database systems
• Ability to complete the organization's clinical training program
• Effective oral and written communication skills
• Essential judgment and decision-making skills
• Ability to accurately follow project work instructions
• Good negotiation skills
• Ability to manage risk and perform appropriate risk escalation
• Occasional drives to site locations
• Potential occasional travel required

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