The Clinical Project Coordinator will be responsible providing operational support to the Clinical department for the planning and execution 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), communicate with clinical site and CRO partners, and implement process improvement initiatives.
- 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 documents
- Collaborate closely with Clinical Team in support of trial execution
- Contact clinical sites and/or CROs to complete study files and regulatory document collections
- Preparation 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 activities
- Assist in the process of executing clinical trial and vendor agreements
- Support 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 process
- Familiarity with setting up and maintaining trial master files and performing file audits preferred
- Understanding of GCPs and knowledge of regulatory requirements preferred
- Proficiency with Microsoft Office suite, particularly MS Excel and MS Word
- 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 (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.