Contract Clinical Project Coordinator
Aveo Oncology - Cambridge, MA

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The Contract Clinical Project Coordinator will be responsible providing operational support to the clinical department for assisting with the planning and coordination of AVEO’s clinical research studies. The Coordinator will provide technical and administrative services for the collection, review, maintenance, and tracking of regulatory documents for clinical study centers, audit trial master files (TMF) and participates/implements process improvement initiatives

Responsibilities:
  • Set up, track, and maintain audit-ready clinical trial documentation in the TMF: Manage and track regulatory/IRB/EC/REB documentation, IND Safety Letter distribution, Confidentiality Disclosure Agreements, and other clinical trial documents
  • Provide support in editing and updating SOPs using Documentum, and electronic filing database
  • Collaborate closely with Trial Managers and Clinical Scientists to collect updated information throughout the life of the trial
  • Contact clinical sites and/or CROs to complete study files and regulatory document collections
  • Create and complete study manuals, binders, tools and presentations with Clinical Scientists’ assistance
  • Review documents and submit them to appropriate departments such as Regulatory Affairs, Clinical Research or Clinical Operations
  • Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors

Qualifications:
  • 2-3 years of clinical trial knowledge/experience and drug development process
  • Prior experience setting up and maintaining trial master files and performing file audits
  • Understanding of GCPs and knowledge of regulatory requirements preferred
  • Experience with Documentum or other web-based filing database is preferred
  • Strong verbal and communication skills
  • Proactive and able to work independently
  • Ability to prioritize and multi-task with attention to detail
  • Strong organizational skills

Aveo Oncology - 10 months ago - save job - block
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