Logistics Coordinator - Santiago, Chile ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. The Logistics Coordinator I will be responsible for the coordination of Investigational Medicinal Product (IMP), Auxiliary Medicinal Product (AxMP), Medical Devices (MD), Electronic Equipments (EE), Laboratory Kits, and associated activities for each study. This responsibility entails ensuring that reception, handling, storage, distribution, reconciliation, returns (if applicable), and destruction operations are conducted promptly and in accordance with the standards such as ICH GCP, ICON SOPs as well as local and international regulations. Overview Of Responsibilities: Coordinate the process to allow import and export of clinical study supplies (may include but not limited to, Investigational Medicinal products (IMP), AxMP, medical device, laboratory kits and equipment): request, compile, complete and/or review necessary documentation, request import/export license approval from competent authorities as applicable; interact with couriers, brokers, and customs authorities. Prepare and submit initial import/export license applications, amendments and/or renewals to competent authorities in accordance with protocol, pharmacy/laboratory manuals and/or study-specific requirements, as applicable. Create and/or review pro forma/commercial invoices and any other relevant documentation for import and/or export, in accordance with local country requirements and client specifications, as applicable. Review and request required changes to pro forma/commercial invoices or any other relevant documentation, to ensure accuracy and completeness; provide approval for shipments as applicable. Liaise effectively with Clinical team - CTM/PM/CRA and/or CSCO teams (CSSM & Distribution team) to ensure country specific requirements are noticed and discussed prior to study related shipments. Liaise effectively with customs authorities, depots, third party vendors including courier companies and brokers regarding study shipments, custom clearance, and delivery. Coordinate study supply distribution to study sites (or authorized destinations) and keep project teams informed of shipment status and issues if any. May oversee Depot activities (Study set-up, receptions, inventory management, shipments scheduled, labeling, returns, destruction, and equipment returned). May perform Reconciliation at country level and destruction coordination with the depot. Manage quality issues regarding IP (e.g. - recall, temperature excursions, product technical complaints, local depot issues). Attend study team teleconferences/meetings in relation to clinical trials logistics as needed. Maintain regular tracking on study related shipments, remaining balance of approved quantity and import/export license validity, as applicable. Support document filing as per ICON SOPs and study requirements. Be familiar with ICH GCP, GxP, relevant ICON SOPs, applicable country legislation and requirements regarding import/export activities and provide country specific logistics expertise to project teams. Contact the study sites and confirm that information regarding missing equipment provided during PSV is current; inform CTM of missing equipment for site, as applicable. For existing equipment at site to collaborate with local monitoring team to make sure that calibration documentation available, as applicable. May be assigned the point of contact for studies internal/external audits in relation to logistics and supplies, could be assigned as Point of Contact (POC) for country specific question and related tasks. Interact directly with the customer on questions of import/export processes. Have a basic knowledge of import/export processes in additional countries as required. Engage in process improvement initiatives. Support other study start up activities as assigned (e.g. collaborate on budgets IMP LCSR per study at country level, performs IMP checklist review and validation in SQV and SIV). Travel (approximately 5%) domestic and/or international. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. #J-18808-Ljbffr