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Clinical Trial Assistant

New Jersey All, NJ

Posted: 09/25/2018 Job Type: Clinical Job Number: JN -092018-22652
  • Responsible for providing in-house support and assistance to assigned study teams
  • Support study teams in administrative tasks, meeting minutes and logistics
  • Prepare and track CDAs
  • Assist with collection and tracking of study documents
  • Create and maintain Study Document Shared Locations
  • Assist with TMF set-up, ongoing quality review, and final reconciliation
  • Send original documents to central TMF, and ensure electronic filing
  • Support Health Authority inspections and CQA audits as required
  • Maintain and update data as appropriate in study management tools
  • Assist with reconciliation of IP
  • Manage local translations, printing for required local documents
  • Manage site file binders activities for in-sourced studies
  • Assist with compilation and QC of Clinical Study Report appendices
  • Support the development/coordination of study training materials
  • Support the study specific training matrix
  • Assist with granting / removing systems and SharePoint accesses
  • Run reports from internal databases and display appropriate formatting
  • Assist with internal and external distribution of IP, documentation, and communication as appropriate
  • Support the production, coordination, completeness and accuracy of IRB/EC submissions for in-sourced studies
Skills/Knowledge Required:
  • At least 2 years in Clinical Operations experience, clinical trial phases, terminology and functional study team roles
  • Good written and oral communications skills with understanding of written and oral English, uses different communication methods appropriately
  • Excellent organizational and administrative skills
  • Experience supporting study teams
  • Self-starter and proactive self-learner
  • Hold self-accountable for actions and results
  • Ability to multi-task effectively and prioritize assignments from multiple sources
  • Ability to work with limited day to day supervision
  • Ability to function productively in a fast paced and rapidly changing environment, demonstrate flexibility
  • Ability to resolve routine problems independently and escalate to management appropriately
  • Identifies and/or supports new solutions, opportunities, and initiatives to improve products, services, and work processes
  • Maintains high quality while meeting deadlines and commitments
  • Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, Powerpoint, Outlook
  • Experience filing paper and electronic study documents, and conducting QC/reviews
  • Experience with IP reconciliation
  • SharePoint experience a plus

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