Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Support audit readiness through scheduled file reviews according to SOPs and department guidance
• Provide administrative support for site activation activities
• Support development of site activation critical paths
• 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 a high-quality standard
• Provide system support for Activate and eTMF and keep databases current
• Process documents for client eTMF, perform eTMF reviews, distribute mailings and communications, and provide documents and reports
• Analyze and reconcile study metrics and findings reports
• Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support translation materials and translation quality control
• Maintain knowledge of SOPs, client directives and regulatory guidelines
• Support client/internal meeting scheduling and local regulatory document tracking
• Support RBM activities and study documentation/system maintenance
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and site selection document collection
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities
• Complete Site Interest Plans in CTMS and collect associated investigator/site 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 site contact and follow-up plans and escalate concerns or non-compliance
• Provide local expertise 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

• Provide administrative and technical support to the Project Team
• Support audit readiness through scheduled department, internal, country, and investigator file reviews
• Provide administrative support for site activation and help develop site activation critical paths
• Develop and review site lists for feasibility activities and contribute local input to site tiering
• Coordinate, oversee, and complete assigned trial activities according to the task matrix
• Document findings in appropriate systems and proactively communicate project risks
• Provide support for Activate and eTMF systems and maintain current databases
• Process and review eTMF documents, distribute mailings and communications, and provide reports to internal teams
• Analyze and reconcile study metrics and findings reports
• Coordinate Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support study-specific translation materials and translation quality control
• Support client/internal meeting scheduling and local regulatory document tracking
• Support RBM activities and study-specific documentation, training tracking, system access, and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers and support regulatory submissions
• Work with sites to obtain site-selection documents and support 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 personnel 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 to meet project deadlines and address site issues and risks
• Maintain site contact and follow-up plans and escalate non-compliance concerns
• Act as a local expert on site capacity and experience, recommend additional sites, and support local site tiering
• 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

• 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
• Communicate project risks to project leads and line manager
• Maintain study-specific documentation, team lists, training requirements, system access, activity plans, and eTMF records
• Provide system support for GoBalto and eTMF
• Support risk-based monitoring activities
• Process trial documents, perform eTMF reviews, conduct mass mailings, and provide documents and reports to internal team members
• Schedule and organize client and internal meetings and complete meeting minutes
• Review and track local regulatory documents
• Transmit documents to the client and centralized IRB/IEC
• Analyze and reconcile study metrics and findings reports and assist with resolving site documentation findings
• Maintain vendor trackers
• Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies to sites
• Assist with study-specific translation materials and translation quality control
• Attend kick-off meetings and take notes when required
• Provide administrative and technical support to the Project Team
• Act as a study lead or cross-functional liaison when required
• Support onboarding as a buddy and train new staff as needed
• Support departmental and cross-functional process improvement initiatives
• Occasional drives to site locations and potential occasional travel