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Clinical Project Associate

Company: Sharp Decisions
Location: San Mateo
Posted on: April 30, 2021

Job Description:

A client of Sharp Decisions Inc. is actively looking to bring on a Clinical Project Associate to be based in Foster City, CA. Position is on a 6 month contract basis to start with possibility for extension. *W2 Only. This position is project involvement and will be in a supportive role. Individual will be preparing agendas, taking meeting minutes, general system updates, SOP review, and other administrative tasks. Backgrounds that has done well in the past has Clinical Research Coordinator titles with a Study Coordination background.Job Responsibilities and Skills

  • Excellent verbal and written communication skills
  • Must be able to work both independently and as part of a team
  • Tracks and prepares study-specific information utilizing databases, spreadsheets and other tools
  • Reviews and participates in the quality assurance of data or documents
  • Arranges meeting logistics, agendas, and assists with minutes
  • Serves as back up providing verbal and written communication with study personnel
  • Assists with development of documents and standard forms
  • Provide input and assist with harmonization of Clinical Operations databases and tracking tools
  • Assist in maintaining clinical information and training of Clinical Operations personnel in the clinical trials management system (GILDA)
  • Serves as CTMA back up providing verbal and written communication with study personnel
  • Interacts with other departments, as directed, to complete assigned tasks
  • May assist with monitoring visits under the direct supervision of senior staff
  • Assists with the planning and facilitation of investigator meetings and, when applicable, provides onsite support during the meetings
  • Knowledge of FDA and EMA Regulations, ICH Guidelines, Google Cloud Platform, and familiarity with standard clinical operating procedures
  • Must be familiar with Word, PowerPoint, and Excel
  • Travel may be requiredMinimum Education and Experience
    • At least 1+ year of experience and a BS or BA in a relevant scientific discipline
    • At least 1+ year of experience and an RN (2 or 3-year certificate) - provided by Dice

Keywords: Sharp Decisions, San Mateo , Clinical Project Associate, Healthcare , San Mateo, California

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