Sr Clinical Trial Associate

Job TitleKey Responsibilities/ Essential Functions Participate in team meetings and draft meeting agendas, minutes, and tracking of action items. Support study teams with administrative tasks and investigational site regulatory document review. Assist in the creation of study materials, including study documents, site and patient-facing materials, presentations, plans, and reports. Prepare and coordinate materials for investigator meetings and monitoring visits such as presentations, templates, outstanding essential document listings. Distribute trial-related materials to sites and/or study team members. Develop and maintain tracking tools for assigned trials to monitor study progress and update study management reports as necessary (e.g., CRO metric compliance, performance indicators, invoices and study payments, patient enrollment).Central contact for designated project communications, correspondence, and associated documentation. Manage clinical study documents that include reviewing for completion, accuracy, and expiration. Coordinate the collection and review of essential documents to authorize initial study drug shipment(s) and site activations. Perform ongoing reviews of TMF inventory for missing and expiring documents, and conduct periodic quality assessments of vendor-managed TMF activities for outsourced studies. Support the maintenance of the Trial Master File (TMF) and assist in quality control as appropriate. Assist with the collection and review of essential documents for completeness and compliance with SOPs, the protocol, and appropriate governmental regulations. Participate in edit check testing and user acceptance testing of study systems. Generate reports or consolidated trackers to assist the study team with patient profile and clinical data reviews. Participate in functional and cross-functional initiatives. Perform other activities as assigned.

Well organized and detail-oriented with strong written and verbal communication skills. Effective time management and organizational skills Significant attention to detail Highly effective interpersonal and customer service skills