Clinical Trial Coordinator

The Clinical Trial Coordinator will coordinate, oversee, and complete functions for assigned trial activities according to the task matrix, ensuring tasks are performed on time, within budget, and to a high-quality standard. This role involves proactively communicating risks to project leads and providing system support for Activate & eTMF, ensuring system databases are current. Responsibilities include performing administrative tasks such as processing documents for the Client (e)TMF, conducting (e)TMF reviews, distributing mailings and communications, and providing documents and reports to internal team members. The coordinator will analyze and reconcile study metrics and findings reports, assist with clarifying and resolving findings related to site documentation, and help coordinate, compile, and distribute Investigator Site File (ISF) and Pharmacy binder materials. They will also assist with study-specific translation materials and translation QC, maintain knowledge of SOPs and regulatory guidelines, and potentially support scheduling meetings, reviewing local regulatory documents, and maintaining study-specific documentation and systems. Additionally, the role involves maintaining vendor trackers, supporting the start-up team in regulatory submissions, assisting with the preparation of regulatory compliance review packages, and coordinating with internal departments to align site activation activities. Collaboration with teammates to achieve project deadlines and communicating with the team and appropriate clinical personnel regarding site issues and risks are also key responsibilities.