Clinical Project Associate II - CA in Foster City, CA at Apex Life Sciences

Date Posted: 5/11/2018

Job Snapshot

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Job Description


  • May assist in the development and upkeep of administrative support tools to the Clinical Operations function including set-up, maintenance and reconciliation of the Trial Master File for studies. 
  • Serves as the point of contact for study sites and contract monitors for clinical supplies, document collection and preparation for close-out visits. 
  • Assists Clinical Operations teams with study set-up (preparation of study materials, Investigator Meeting planning, etc.) 
  • Develops and keeps Clinical Trial tracking program up to date with site contact, initiation and enrollment details 
  • Demonstrates an ability to and takes the initiative to independently apply knowledge of administrative support 
  • Demonstrates a deeper understanding of the science behind Clinical Operations 
  • 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. 
  • The position interacts with other departments, as directed, to complete assigned tasks. 
  • May assist with monitoring visits under the direct supervision of senior staff. Travel may be required. 
  • Assist with the planning and facilitation of investigator meeting and, when applicable, provide on location support during the meetings.