Clinical Trial Coordinator

• 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
• Aid development of the site activation critical path to support rapid site activations
• Develop and review site lists using local knowledge, organization systems, external site lists and sponsor directives
• Provide local input into site tiering for feasibility activities
• Coordinate, oversee and complete assigned trial activities according to the task matrix
• Perform department, internal, country and investigator file reviews and document findings in appropriate systems
• Ensure allocated tasks are completed on time, within budget and to a high-quality standard; communicate risks to project leads
• Support and maintain Activate, eTMF and other clinical trial systems and databases
• Process documents for client eTMF, perform eTMF reviews, distribute communications and provide reports to internal team members
• Analyze and reconcile study metrics and findings reports; assist with resolving site documentation findings
• Coordinate, compile and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support study-specific translation materials and translation quality control
• Schedule client and internal meetings as needed
• Review and track local regulatory documents
• Support risk-based monitoring activities and study-specific documentation, training requirements, system access and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and site selection documentation
• Assist with regulatory compliance review packages and coordinate with internal departments on site start-up activities
• Complete Site Interest Plans in CTMS and collect associated investigator and 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 to meet deadlines and address site issues and risks
• Maintain efficient site contact and follow-up plans, escalating concerns and non-compliance to management
• Act as a local expert on site capacity and experience; identify and develop new sites and support local site tiering
• Liaise with Global Investigator Services to resolve investigator queries and maintain account and contact information
• Contribute to global strategic feasibility processes and best practices
• Train new personnel in processes and systems
• May conduct on-site feasibility visits in Asia Pacific

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• 0 to 1 year of previous experience providing relevant knowledge, skills, and abilities
• Combination of appropriate education, training and/or directly related experience may be considered equivalent
• Ability to work independently or in a team
• Good organizational skills and strong attention to detail
• Ability to manage 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 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 required

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