Clinical Trial Coordinator, Experienced

The Clinical Trial Coordinator will provide administrative and technical support to the Project Team, ensuring audit readiness by reviewing files and aiding in site activation. They will develop collaborative relationships with investigators and site personnel, and support the training of new staff and departmental initiatives for process improvements. Responsibilities include coordinating and completing functions on assigned trial activities, performing file reviews and documenting findings, and proactively communicating risks. The role involves performing administrative tasks such as processing documents for the (e)TMF, conducting (e)TMF reviews, distributing mass mailings, and providing documents and reports. Additionally, they will review and track local regulatory documents, maintain vendor trackers, analyze and reconcile study metrics, and assist with resolving findings related to site documentation. Maintaining knowledge of SOPs, client directives, and regulatory guidelines, ensuring accurate trial status information in the database, and training new personnel are key duties. The coordinator will ensure the (e)TMF is up-to-date, may support meeting scheduling and minutes, assist with start-up activities and regulatory submissions, and collaborate with teammates to achieve project deadlines. They will also connect with team members and clinical personnel regarding site issues and risks, and may act as a local expert on site capacity and experience.