Clinical Trial Coordinator I

• Provide administrative and technical support to the Project Team
• Support audit readiness by reviewing files according to organizational SOPs and department guidance
• Provide administrative support for site activation activities and help develop site activation critical paths
• Develop and review site lists for feasibility activities and provide local input to site tiering
• Coordinate, oversee, and complete assigned 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 for Activate and eTMF and keep system databases current
• Process documents sent to the client eTMF, perform eTMF reviews, distribute communications, and provide reports
• Analyze and reconcile study metrics and findings reports
• Assist with resolving findings related to site documentation
• Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support study-specific translation materials and translation quality control
• Maintain knowledge of applicable SOPs, client directives, and regulatory guidelines
• Support client/internal meeting scheduling and tracking of local regulatory documents
• Support RBM activities and study documentation, training requirements, system access, and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and prepare regulatory compliance review packages
• Work directly with sites to obtain site-selection documents
• Coordinate with internal departments to align site start-up activities with the activation critical path
• Complete Site Interest Plans in CTMS and collect associated investigator/site personnel documents
• Document site communications, follow-ups, and survey responses in real time
• Review survey data for logical, complete, and relevant responses
• Collaborate with teammates and clinical personnel regarding site issues and risks
• Establish and monitor site-contact follow-up plans and escalate concerns or non-compliance
• Act as a local expert on site capacity and experience and recommend additional sites
• Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information
• Contribute to global strategic feasibility processes and best practices
• Train new personnel in processes and systems
• Use local knowledge to identify and develop new sites

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• Previous experience comparable to 0 to 1 year
• Equivalency may be considered through a combination of appropriate education, training and/or directly related experience
• 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 according to changing project timelines
• 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
• 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
• Self-motivated with a positive attitude and good interpersonal skills
• Effective oral and written communication skills
• Essential judgment and decision-making skills
• Ability to accurately follow project work instructions
• Good negotiation skills
• Independent thinking
• Ability to manage risk and perform appropriate risk escalation
• Occasional drives to site locations and potential occasional travel

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