Clinical Project Coordinator

Company: AVEO Oncology
Location: Somerville
Posted on: January 12, 2021

Job Description:

Position DescriptionThe Clinical ProjectCoordinator will be responsible providing operational support to the Clinicaldepartment for the planning and execution of AVEO---s clinical research studies.The Coordinator will provide technical and administrative services for thecollection, review, maintenance, and tracking of regulatory documents forclinical study centers, audit trial master files (TMF), communicate withclinical site and CRO partners, and implement process improvement initiatives. Responsibilities:Set up, track, and maintain audit-ready clinical trial documentation in TMF: Manage and track regulatory/IRB/EC documentation, IND Safety Letter distribution, Confidentiality Disclosure Agreements, and other clinical trial documentsCollaborate closely with Clinical Team in support of trial executionContact clinical sites and/or CROs to complete study files and regulatory document collectionsPreparation and review of study-specific site documents, such as ICFs, subject diaries, study reference manuals, site tools, and presentations, etc. Support planning and logistics for all clinical trial activitiesAssist in the process of executing clinical trial and vendor agreementsSupport planning and logistics for internal and external meetings and preparation of agendas, meetings, and meeting minutes Qualifications & Requirements:1-2 years of clinical trial knowledge/experience and drug development processFamiliarity with setting up and maintaining trial master files and performing file audits preferredUnderstanding of GCPs and knowledge of regulatory requirements preferredProficiency with Microsoft Office suite, particularly MS Excel and MS Word Strong verbal and communication skillsProactive and able to work independentlyAbility to prioritize and multi-task with attention to detailStrong organizational skillsAVEO Oncology (NASDAQ: AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO---s proprietary Human Response Platform--- has delivered unique insights into cancer and related disease biology that AVEO is seeking to leverage in the clinical development strategy of its therapeutic candidates. Notice: JavaScript is required for this content.

Keywords: AVEO Oncology, Somerville , Clinical Project Coordinator, Other , Somerville, Massachusetts