Clinical Trial Associate

Berkeley  ‐ Onsite
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Keywords

Description

Responsibilities:
  • Set up CTMS system, as appropriate
  • Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations
  • Handle incoming and outgoing shipments, as needed
  • Assist with all aspects of initial study drug release including regulatory packet review and study-drug release
  • Assist in the preparation of study-specific training materials
  • Participate in the planning of investigator meetings
  • Assist in the development of case report forms and participate in the EDC and IVRS specification process, as appropriate
  • File clinical documents and maintain clinical research files (ie, central files for studies)
  • Participate in support of regional Field Monitors
  • Interact with sites as needed to respond to issues
  • Monitor and track ALL monitoring visit reports (per CTMS)
  • Assist with tracking of clinical trial progress including status update reports, as required
  • Participate in the review of clinical data at the case report form, data listing, and report table levels
  • Assist with final sign off of project and study-related documents including: informed consent forms, monitoring plans, synopses, protocols and amendments, IND Annual Updates, NDAs, and other documents, as required
  • Participate in clinical teams, including attending required meeting, and interact in a positive, professional manner
  • Maintain training update to date including review and sign off of SOPs
  • Identify and escalate issues appropriately
  • Perform other duties as assigned
  • Set up clinical trials in 'Clinicaltrial.gov' and maintain until end-of-study


Requirements:
  • BA/BS in scientific discipline is highly preferred, but not required
  • 2 years + experience in the pharmaceutical/clinical research environment
  • Able to prioritize and handle multiple tasks simultaneously
  • Must have demonstrated expertise in relevant clinical operations activities
  • Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
  • Working knowledge of ICH/GCP guidelines and FDA regulations
Start date
08/2014
From
Real Staffing
Published at
12.08.2014
Project ID:
756596
Contract type
Freelance
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