Clinical Trial Coordinator II

• Coordinate, oversee, and complete assigned trial activities according to the task matrix
• Perform department, internal, country, and investigator file reviews and document findings
• Ensure allocated tasks are completed on time, within budget, and to a high-quality standard
• Process documents sent to the client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports
• Review and track local regulatory documents
• Analyze and reconcile study metrics and findings reports
• Maintain vendor trackers
• Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support study-specific translation materials and translation quality control
• Provide technical and administrative project support in collaboration with internal departments and team members
• Maintain accurate trial status information in databases
• Develop and maintain relationships with client local affiliates where applicable
• Conduct on-site feasibility visits where applicable (Asia Pacific only)
• Train new personnel in processes and systems
• Maintain study documentation, team lists, training requirements, system access, and activity plans
• Provide system support for Activate and eTMF and support RBM activities
• Transmit documents to clients and centralized IRB/IEC
• Attend kick-off meetings and take notes when required
• Schedule and organize client/internal meetings and prepare minutes
• Coordinate with internal departments to align site start-up activities with the site activation critical path
• Assist with regulatory compliance review packages and regulatory submissions
• Obtain site-selection documents and develop site lists from internal and external sources
• Maintain investigator and site staff contact details in company systems
• Complete Site Interest Plans in CTMS and document site communications and follow-up
• Review survey data for logical, complete, and relevant responses
• Collaborate with teammates to meet project deadlines and communicate site issues and risks
• Conduct phone interviews with physicians and site personnel to support trial optimization
• Liaise with Global Investigator Services to resolve investigator queries
• Contribute to global strategic feasibility processes and best practices

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years)
• Bachelor's degree preferred
• Ability to work in a team or independently
• Strong organizational skills and attention to detail
• Ability to analyze project-specific data/systems
• Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
• Excellent 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
• Effective oral and written communication skills
• Strong interpersonal, presentation, negotiation, organizational, and planning skills
• Basic medical/therapeutic area and medical terminology knowledge
• Basic knowledge of local health systems
• Working knowledge of GCP and applicable SOPs
• Ability to work in a matrix environment
• Ability to manage risk and perform risk escalation appropriately
• Occasional drives to site locations and potential occasional travel

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