Clinical Trial Coordinator in Summit, NJ at Apex Life Sciences

Date Posted: 5/25/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Summit, NJ
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    5/25/2018
  • Job ID:
    852945

Job Description


Summary/Scope: 

  • The Clinical Trial Coordinator is responsible for providing in-house support and assistance to assigned study teams and Trial Manager.

Responsibilities: 

Project Management: 

  • Support study teams in administrative tasks and logistics (i.e. expenses, travel arrangements, meeting set-up including investigator meetings).
  • Create and maintain Study Document Shared Locations for assigned study(ies) on the Central Repository.
  • File and maintain the study administrative files locally and send original documents to central TMF.
  • When applicable, ensure electronic filing. 
  • Support Health Authority inspections and CQA audits as required.
  • Maintain and update data as appropriate in study management tools including CTMS, National Clinical Trial Databases, etc. as appropriate.
  • Assist with reconciliation of IP at study level
  • Manage local translations and printing for required local documents 
  • Support contract implementation as required 

Study Planning and Conduct:

  • Assist with TMF set-up, ongoing quality review, and final reconciliation 
  • Assist with collection of appropriate country/site insurance 
  • Assist with management of study-level IP shipment to sites as necessary 
  • Support the development/coordination of study training materials 
  • Support the collection and tracking of study documentation as necessary 
  • Assist with compilation of Clinical Study Report appendices 
  • Assist with granting / removing systems and Sharepoint accesses 
  • Support the study specific training matrix 
  • Manage site file binders activities for in-sourced studies 
    • submit documents to TMF/eTMF 
    • assist with SUSAR listings 

Requirements: 

  • 2 years of clinical operations experience within a pharmaceutical or CRO environment
  • Good written and oral communications skills with understanding of written and oral English 
  • Ability to multi-task effectively and prioritize assignments from multiple sources 
  • Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, Powerpoint, Outlook (ability to manage calendars/inboxes). 
  • SharePoint experience a plus. 
  • Strong Knowledge of regulatory documents, study design 
  • Experience filing study documents, and conducting QC/reviews 
  • Experience supporting study teams, awareness of what role functional team members play on a study team and general understanding of the tasks the functions handle - data management - safety, science, IMSC, IVRS, etc. 
  • Experience with IP reconciliation 

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