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
• Develop and review site lists for feasibility activities and provide local input into 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
• Ensure allocated tasks are completed on time, within budget and to quality standards
• Provide support for Activate and eTMF systems and keep databases current
• Process documents for the client eTMF, perform eTMF reviews, distribute communications and provide reports
• Analyze and reconcile study metrics and findings reports
• Assist with resolution of site documentation findings
• Coordinate and distribute Investigator Site File, Pharmacy binder materials and non-clinical study supplies
• Support study-specific translation materials and translation quality control
• Maintain knowledge of SOPs, client directives and regulatory guidelines
• Conduct on-site feasibility visits where applicable in Asia Pacific
• Support client and internal meeting scheduling
• Review and track local regulatory documents where applicable
• Support risk-based monitoring activities where applicable
• Maintain study documentation and systems, including team lists, training requirements, system access and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and site start-up activities
• Work directly with sites to obtain site-selection documents
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities with the activation critical path
• Complete Site Interest Plans in CTMS and collect associated 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
• Maintain an effective site contact and follow-up plan and escalate concerns
• 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 accurately and efficiently
• 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
• Judgment and decision-making skills
• Ability to accurately follow project work instructions
• Good negotiation skills
• Independent thinking
• Ability to manage risk and perform risk escalation appropriately

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