Clinical Trial Coordinator I

• Provide administrative and technical support to the Project Team
• Support audit readiness through scheduled file reviews according to SOPs and department guidance
• Support site activation activities and development of site activation critical paths
• Develop and review site lists for feasibility activities and contribute to local 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
• Complete allocated tasks on time, within budget and to quality standards; communicate risks to project leads
• Provide system support for Activate and eTMF and keep databases current
• Process documents to client eTMF, perform eTMF reviews, distribute communications, and provide reports
• Analyze and reconcile study metrics and findings reports
• Coordinate 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, regulatory document tracking, RBM activities, study documentation, training tracking and access management
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and preparation of regulatory compliance review packages
• Work directly with sites to obtain site-selection documents
• Coordinate with internal departments to align site start-up activities with the critical path
• Document site communications and follow-up in real time and review survey data
• Collaborate with teammates and clinical personnel regarding site issues and risks
• Maintain plans for site contact and follow-up and escalate 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 feasibility processes and best practices
• Train new personnel in processes and systems
• Contribute to identification and development of 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 through a combination of appropriate education, training and/or directly related experience may be considered
• 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 for accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload
• 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 (Word, Excel, and PowerPoint)
• Ability to learn clinical trial database systems
• Ability to successfully complete the organization's clinical training program
• Effective oral and written communication skills
• Judgment and decision-making skills
• Ability to follow project work instructions accurately
• Negotiation skills
• Ability to manage risk and perform risk escalation appropriately
• Occasional travel may be required

• Fully remote work arrangement
• Full-time employment