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Clinical Trial Assistant

New Jersey All, NJ

Posted: 02/20/2019 Job Type: Clinical Job Number: JN -022019-23730

Responsible for supporting the Clinical Trial Management/operational study team to manage the various aspects of the operational execution and delivery of quality studies, including in process quality control activities.

Primary responsibilities of this position include:
  • Supports the Clinical Trial Management/operational study teams in the execution and delivery of studies
  • Support study feasibility activities and perform database/web searches for sites as needed
  • Work closely with the Site Start Up (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation
  • 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
  • Track and assist with processing site/vendor payments; follow up on any issues as required
  • Collect and track patient enrollment information and update study management reports as necessary
  • 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 in the planning, preparation, and on-site support of investigators meetings
  • Generate reports in various applications to assist the Clinical Trial Managers to perform clinical data review
  • 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
  • Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies)
Additional 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 and CTM hires within department
  • May provide administrative support to manager/group as assigned
  • Manage calendars and appointments; resolve scheduling conflicts as needed
  • Manage and coordinate travel requirements for group, consultants, and partners
  • Prepare and oversee expense account reporting
  • May contribute to tracking budgets as needed
  • Support document filing and organizing as needed
  • Schedule and coordinate new hire candidate interviews
  • Coordinate and process office supply orders
  • Function as a back up to general Clinical Trial Manager activities as needed
  • Bachelor s Degree with 2 years of Clinical Trial Assistant/Associate experience from a pharmaceutical or CRO company
  • Knowledge of drug development and FDA GCP/ICH regulatory guidelines
  • Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat
  • Strong skills with Microsoft Excel is required
  • Experience using electronic data capture (EDC) systems
  • Excellent oral and written communication
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