[Remote] Clinical Trial Coordinator at Thermo Fisher Scientific

The Clinical Trial Coordinator will perform file reviews, document findings, and ensure allocated tasks are completed on time, within budget, and to a high-quality standard, proactively communicating any risks. They will provide system support, maintain current system databases, and perform administrative tasks such as processing documents for the client (e)TMF, performing (e)TMF reviews, distributing mailings, and providing documents and reports. Responsibilities also include analyzing and reconciling study metrics and findings reports, assisting with clarification and resolution of documentation findings, and coordinating the distribution of Investigator Site File and Pharmacy binder materials. The role involves assisting with study-specific translation materials and QC, maintaining knowledge of regulatory guidelines, and potentially supporting RBM activities and the maintenance of study-specific documentation and systems. Additionally, the coordinator will transmit documents to the client and IRB/IEC, maintain vendor trackers, support the start-up team in regulatory submissions, and work directly with sites to obtain documents for site selection.