Job Details

  • Title: Clinical Project Associate
  • Code: RCI-08809
  • Location: Santa Monica California (CA) 90404
  • Posted Date: 09/15/2020
  • Duration: 12 Months
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  Job Description

  • Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools
  • Provide input and assist with harmonization of Clinical Operations databases and tracking tools
  • Assist in the maintaining clinical information and training of Clinical Operations personnel in the clinical trials database
  • Processes re-supply drug shipments
  • Order and maintain inventory of clinical supplies. Order and ships case report forms
  • Assists with development of documents for site binders
  • Assembles and coordinates distribution of site binders
  • Serves as CRA back up providing verbal and written communication with study personnel
  • Under close supervision reviews and participates in the quality assurance of data or documents
  • Arranges meeting logistics
  • Drafts meeting agendas and assists in preparing meeting minutes
  • Interacts with other departments, as directed, to complete assigned tasks
  • May assist with monitoring visits under the direct supervision of senior staff
  • Assist with the planning and facilitation of investigator meeting and, when applicable, provide on location support during the meetings
  • Experience with Electronic Trial Master File (eTMF) is highly preferred
  • Excellent verbal and written communication skills and interpersonal skills are required
  • Must be familiar with Word, PowerPoint, and Excel
  • Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus
  • Must be able to work both independently and as part of a team
  • Travel may be required