Clinical Trial Coordinator

The Clinical Trial Coordinator will coordinate, oversee, and complete functions for assigned clinical trials, ensuring tasks are performed on time, within budget, and to a high-quality standard. They will proactively communicate risks, provide system support for platforms like Activate & eTMF, and maintain current system databases. Administrative tasks include processing documents, performing eTMF reviews, distributing mailings, and providing documents and reports. The role involves analyzing and reconciling study metrics, assisting with findings clarification, and coordinating the distribution of Investigator Site File materials and non-clinical study supplies. Responsibilities also include assisting with study-specific translation materials and quality control, maintaining knowledge of SOPs and regulatory guidelines, and potentially scheduling meetings. The coordinator may also review and track local regulatory documents, support the maintenance of study documentation and systems, maintain vendor trackers, and assist the start-up team with regulatory submissions and compliance review packages. Collaboration with internal departments and teammates to achieve deadlines and communicate site issues and risks is also a key responsibility.