Clinical Trial Coordinator

• 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 a high quality standard
• Communicate project risks to project leads and line manager
• Process documents sent to the client eTMF, perform eTMF reviews, distribute mass mailings, and provide documents and reports to internal team members
• Review and track local regulatory documents
• Analyze and reconcile study metrics and findings reports
• Assist with clarification and resolution of site documentation findings
• Maintain vendor trackers
• 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
• Provide technical and administrative project support in collaboration with internal departments and team members
• Maintain knowledge of SOPs, client directives, and applicable regulatory guidelines
• Maintain accurate and current trial status information in databases
• Develop and maintain relationships with client local affiliates where applicable
• Champion inclusion of Strategic Collaboration sites
• Conduct on-site feasibility visits where applicable for Asia Pacific roles
• Train new personnel in processes and systems
• Maintain study documentation, team lists, training requirements, system access, and project activity plans
• Provide support for Activate, eTMF, and risk-based monitoring 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 meeting 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 directly from sites when needed
• Develop site lists and maintain investigator/site staff contact details
• Complete Site Interest Plans in CTMS and document site communications and survey responses
• Review survey data for logical, complete, and relevant responses
• Collaborate with teammates to meet project deadlines and address site issues and risks
• Ensure effective site contact and follow-up plans and escalate non-compliance
• Serve as a local expert on site capacity and experience and support local site tiering
• Conduct phone interviews with physicians and site personnel to obtain protocol-level input
• Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information
• Contribute to global strategic feasibility processes and best practices

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
• Provide system support for Activate and eTMF and keep system databases current
• Process documents for the Client eTMF, perform eTMF reviews, distribute communications, and provide reports
• Analyze and reconcile study metrics and findings reports
• 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
• Maintain knowledge of SOPs, client directives, and regulatory guidelines
• Support client and internal meeting scheduling
• Review and track local regulatory documents
• Support risk-based monitoring activities and study documentation systems
• Maintain study team lists, training requirements, system access, and project activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and regulatory compliance review packages
• Work with sites to obtain site-selection documents
• Coordinate 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
• Document communications, follow-up, 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
• Ensure site-contact and follow-up plans are implemented 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

Clinical Trial Coordinator jobs in North Carolina

Clinical Trial Coordinator II

FSP Clinical Trial Coordinator