Sr Clinical Trial Coordinator / Clinical Trial Coordinator II

The Clinical Trial Coordinator will provide administrative and technical support to the project team, coordinating and facilitating project activities, and potentially serving as a study lead. They will act as a buddy for new staff during onboarding and provide training as needed, while also supporting departmental and cross-functional process improvement initiatives. Specific duties include coordinating and completing assigned trial activities, performing file reviews and documenting findings, ensuring tasks are completed on time and to high standards, and proactively communicating risks. Responsibilities also involve maintaining study documentation and global support systems, managing system access, tracking project-level activity plans, and ensuring the eTMF is up-to-date. The role includes providing system support for tools like GoBalto and eTMF, supporting RBM activities, processing documents, performing eTMF reviews, handling mass mailings, and providing documents and reports. Additionally, the coordinator will support meeting scheduling, review regulatory documents, transmit documents to clients and IRBs, analyze and reconcile study metrics, maintain vendor trackers, and assist with the coordination and distribution of Investigator Site File materials and supplies. They may also assist with translation materials and attend kick-off meetings.