Clinical Project Coordinator
Company: AVEO Oncology
Location: Somerville
Posted on: January 12, 2021
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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
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Keywords: AVEO Oncology, Somerville , Clinical Project Coordinator, Other , Somerville, Massachusetts
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