Clinical Trial Coordinator I

• Provide administrative and technical support to the Project Team
• Support audit readiness through scheduled department, internal, country, investigator, and eTMF file reviews
• Coordinate, oversee, and complete assigned trial activities according to the task matrix
• Support site activation activities and development of site activation critical paths
• Develop and review site lists for feasibility activities and contribute local input to site tiering
• Ensure allocated tasks are completed on time, within budget, and to quality standards
• Provide system support for Activate and eTMF and keep databases current
• Process and transmit documents to client eTMF and centralized IRB/IEC
• Distribute mass mailings, communications, documents, reports, ISF, pharmacy binder materials, and non-clinical study supplies
• Analyze and reconcile study metrics and findings reports
• Assist with resolution of site documentation findings
• Support study-specific translation materials and translation quality control
• Maintain study documentation, team lists, training requirements, system access, activity plans, vendor trackers, and regulatory documents
• Support regulatory submissions and preparation of regulatory compliance review packages
• Work with sites to obtain site-selection documents and coordinate site contact and follow-up
• Review survey data for logical, complete, and accurate responses
• Communicate site issues and risks to clinical personnel and escalate concerns or non-compliance
• Liaise with Global Investigator Services to resolve investigator queries and maintain account and contact information
• Contribute to global feasibility processes and best practices
• Train new personnel and act as a buddy during onboarding
• Utilize local knowledge to identify and develop new sites

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Previous experience comparable to 0 to 1 year
• Bachelor's degree preferred
• Good English language and grammar skills and proficient local language skills as needed
• Proficiency in MS Office (Word, Excel, and PowerPoint)
• Ability to learn and master clinical trial database systems
• Ability to successfully complete the organization’s clinical training program
• Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
• Ability to work independently or as part of a team
• Strong organizational skills and attention to detail
• Ability to manage multiple tasks efficiently
• Ability to analyze project-specific data and systems
• Flexibility to reprioritize workload according to changing timelines
• Effective oral and written communication skills
• Judgment and decision-making skills
• Ability to accurately follow project work instructions
• Negotiation skills
• Ability to manage risk and escalate appropriately
• Occasional travel and drives to site locations may be required

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