Contract Senior Clinical Research Associate (in-house)
Aveo Oncology - Cambridge, MA

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We are seeking a contract Sr. Clinical Research Associate to join a fast growing Clinical Operations team at AVEO. The incumbent will have the following responsibilities:
  • Independently perform all types of monitoring visits and/or co-monitors with CRO/contract monitors to ensure quality site conduct and data entry
  • Ensure GCP and local regulatory compliance
  • Conduct review and approval of Site activation
  • Demonstrates independent site management capabilities (compliance, deliverables, relationship, and troubleshooting)
  • Track study progress ensuring timely data collection, monitoring, and query resolution
  • Oversee site compliance with study protocol
  • Assist in the creation and review of informed consents, case report forms, study operations manuals, monitoring tools, and other study-related materials
  • Review monitoring visit reports to identify potential site non-compliance and monitoring deficiencies and ensure sponsor oversight
  • Ensure timely safety reporting at assigned investigative sites
  • Participate in data listings review

Qualifications:
  • BS/BA degree or equivalent (background in life sciences preferred)
  • 3+ yrs of industry experience (biotech/pharma/ CRO) as a monitor
  • At least 2 years oncology monitoring experience
  • Ability to manage timelines and vendors
  • Strong understanding of ICH, GCP, and relevant regulatory requirements
  • Good communication skills and proficiency with Microsoft Outlook, Excel, Word and PowerPoint.
  • Ability travel up to 20% of time

Aveo Oncology - 18 months ago - save job - copy to clipboard
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