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Clinical Trial Administrator
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Clinical Trial Administrator

Job Description

The Clinical Trial Administrator will ensure that the client project is consistently delivered to the highest quality level possible, complying with applicable regulations, client expectations, company policies and procedures.  This position provides full clinical and logistical support to the client company and to Phlexglobal as required. Key responsibilities of this six month temporary position include:
   
  • Pre Audit/ Inspection review of Trial Master File (TMF) documentation in accordance with Phlexglobal or Client Company Standard Operating Procedures (SOPs). 
  • Review of client documentation with respect to content, cross-section referencing and compliance with appropriate regulations
  • Set-up and maintenance of TMF and Investigator Site Files on behalf of the client company, in accordance with the client SOPs, Phlexglobal SOPs and ICH GCP
  • Perform Quality control review of TMF to ensure all essential documents are within the file, in the appropriate sections
  • Compiliation, copying, distribution and filing of essential study documentation
  • Scanning and indexing of study documentation
  • Provision of tracking logs and templates for client companies for use in ongoing studies
  • Preparation of documentation for Archive, in accordance with Phlexglobal SOPs and industry standards
  • Provide support to other Phlexglobal departments as and when required
  • Additional duties as requested

Job Requirements

  • Must be able to travel to client site, including overnight stays to support project work
  • Excellent working knowledge of the TMF is required.
  • Experience working in the a Clinical Research environment
  • Advanced skills in MS word, Excel and Outlook
  • Demonstrates good understanding of ICH GCP and EU Directive
  • Pro-active, initiative driven
  • Excellent attention to detail
  • Excellent verbal and written communication skills
  • Ability to work independently or prioritize and seek input where necessary
  • Ability to travel and work at client premises
  • Focused, starter-finisher, flexible approach
  • Helpful, outgoing team worker

Job Snapshot

Employment Type Seasonal/Temp
Job Type Health Care
Education Not Specified
Experience At least 1 year(s)
Manages Others No
Relocation No
Industry Healthcare - Health Services
Required Travel Not Specified
Job ID PXGUSCTA AUG2014
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Clinical Trial Administrator


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