Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Support audit readiness by reviewing files according to organizational SOPs and departmental guidance
• Coordinate, oversee, and complete assigned clinical trial activities according to the task matrix
• Perform department, internal, country, and investigator file reviews and document findings
• Complete allocated tasks on time, within budget, and to a high-quality standard; communicate risks to project leads
• Provide system support in Activate and eTMF and keep system databases current
• Process documents for client (e)TMF, perform (e)TMF reviews, distribute mailings and communications, and provide documents and reports
• Analyze and reconcile study metrics and findings reports
• Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support translation materials and translation quality control
• Support site activation, feasibility, site selection, site tiering, and regulatory submissions
• Coordinate with sites to obtain site-selection documents and resolve investigator queries
• Prepare regulatory compliance review packages
• Maintain study documentation, trackers, team lists, training requirements, system access, and project activity plans
• Document site communications, follow-ups, and survey responses in real time
• Review survey data for logical and complete responses
• Collaborate with teammates and clinical personnel regarding site issues and risks
• Train new personnel in processes and systems
• Contribute to global strategic feasibility processes and 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
• In some cases, an equivalency consisting of appropriate education, training and/or directly related experience may be considered
• Ability to work in a team or independently
• 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
• Working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
• Good English language and grammar skills and proficient local language skills as needed
• Proficient 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
• 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 risk escalation appropriately

• Fully remote work mode
• Standard Monday–Friday work schedule
• Training through the organization's clinical training program
• Potential occasional travel to site locations