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Clinical Trial Associate

New Jersey All, NJ

Posted: 11/05/2018 Job Type: Clinical Job Number: JN -112018-22969
  • Assist the Operations Specialist in planning, managing and coordinating assigned Phase 1 studies
  • Support study feasibility activities and perform database/web searches for sites as needed
  • Organize and maintain project working files and track critical documents
  • Report discrepancies to the appropriate clinical team member in a timely manner
  • Reconcile and transmit all essential documentation to electronic data repository system
  • Track invoices and submit POs
  • Create distribution lists
  • Assist in the preparation of monitoring documents
  • Prepare protocol review slides
  • Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems
  • Assist senior team members with the planning, preparation, and on-site support of investigators meetings
  • Generate reports in various applications to assist the Operations Specialist to perform clinical data review
  • Assist with ongoing data review and discuss comments with the clinical study team as needed
  • Assist with the preparation and distribution of meeting agendas and minutes
  • Actively participate in team meetings
  • Support the Regional Site Managers by providing study related information and supplies, as requested
  • Communicate with IRBs and outside vendors to provide information and/or resolution to specific requests/issues
Additional job responsibilities:
  • Contribute to process improvement efforts including task forces and committees
  • Support clinical team with requests from management as needed
  • May deliver training related to day-to-day responsibilities for new CTA hires within department
  • May provide administrative support to manager/group as assigned
  • Support document filing and organizing as needed
  • Schedule and coordinate new hire candidate interviews
  • Function as a back up to general Clinical Operations Specialist activities as needed
Qualifications:
  • Associate degree or higher preferred
  • Experience supporting clinical trials as a CTA with a pharm/biotech/CRO organization
  • Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat
  • Strong skills with Microsoft Excel required
  • Experience using electronic data capture (EDC) systems
  • Attention to detail
  • Adherence to timelines
  • Good organizational and interpersonal skills
  • Excellent written and oral communication skills
  • Ability to manage multiple tasks


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