Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Support audit readiness by reviewing files according to SOP and department guidance schedules
• Provide administrative support for site activation activities and help develop site activation critical paths
• Develop and review site lists using local knowledge, systems, external site lists and sponsor directives
• Contribute local input to site tiering and 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
• Complete allocated tasks on time, within budget and to quality standards; communicate risks to project leads
• Provide system support for Activate and eTMF and maintain current databases
• Process documents for client eTMF, conduct eTMF reviews, distribute mailings and communications, and provide reports
• Analyze and reconcile study metrics and findings reports; assist with resolving site documentation findings
• Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support translation materials and translation quality control
• Follow applicable SOPs, client directives and regulatory guidelines
• Support client/internal meeting scheduling, regulatory document tracking and RBM activities as applicable
• Maintain study documentation, team lists, training requirements, system access and project activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers and support regulatory submissions
• Obtain site-selection documents directly from sites
• 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 investigator/site documents when applicable
• 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, risks and deadlines
• Maintain an efficient site-contact and follow-up plan 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 feasibility processes and best practices
• Train new personnel in processes and systems
• Utilize local knowledge to identify and develop new sites

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• 0 to 1 year of previous comparable experience
• Ability to work independently or in a team
• Strong organizational skills and attention to detail
• Ability to manage multiple tasks efficiently and effectively
• Ability to analyze project-specific data and systems accurately
• 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 appropriate risk escalation
• Occasional driving to site locations and potential occasional travel

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Potential occasional travel
• Clinical training program