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Sr. Clinical Trial Associate

Location
Cambridge, MA

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Clinical Trial Associate The Sr. Clinical Trial Associate will provide a senior prsense for all operations with our CROs and Sites. The Sr. CTA provides clinical study administrative support and Trial Master File (TMF) support for clinical operations. The incumbent also provides support to clinical operations by reviewing vendor invoices for accuracy against budget, tracking vendor payments and taking meeting minutes during project team meetings.\rThe incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues. \rThe Sr. Clinical Trial Associate supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.\rResponsibilities include, but are not limited toAssists with preparing and editing, tracking, and routing clinical development documents, e.g., clinical protocols, informed consents, etc., as requested. Assists with development and production of study materials, essential documents, presentations, reports, submissions, articles, and other materials; prepares clinical study conduct binders; tracks and files routine clinical study documents, either generated internally or received from Clinical Research Organizations (CROs), including, but not limited to: meeting agendas, minutes, status or patient trackers, patient screening logs and other documents as appropriate.Reviews vendor invoices for accuracy against budget. Liaises with Finance, or delegates, to ensure payments are made and tracked.Assists in preparation for regulatory audits or partnering discussion.Quality checks clinical TMF documents, including clinical study site documents, email correspondence, training materials, and other study documents; generates filing indexes and maintains currents lists of correspondence.Provides appropriate administrative support, version control, and document tracking for SOPs, other documents maintained under Clinical control.Performs other tasks and assignments as needed and specified by management.\rRequirementsBachelors degree required3 years of previous Clinical Trial Associate experience requiredOncology experience preferred\rReference number: BBBH49491

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