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Clinical Trial Associate

New Jersey All, NJ

Posted: 06/20/2019 Job Type: Clinical Job Number: JN -062019-25117
  • Responsible for providing operational and program level support for several Phase I/II clinical trials
  • This support includes planning, set-up, maintenance and closeout of trials as applicable
  • Support the group in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards
  • Assigned responsibilities can include development of specific sections of related study documents (e.g. sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans
  • Support by setting up and maintaining appropriate study tracking forms including: enrollment log/trial allocations forms, site and vendor contact lists, drug shipping logs, set up and maintenance of team membership and contact lists
  • Support in managing interactions with relevant functions including Drug Supply Management and local organizations (CPOs)
  • Support with all US drug supply shipping (initial and re-supply) to local CPO and all US sites to ensure timely SIV and uninterrupted patient treatment
  • Function as the liaison with US local depot to ensure drug delivery and relabeling occur in a timely fashion and track all drug at the central hubs
  • Support in all drug tracking (central hubs, local CPOs and sites) to ensure adequate supply, monitor expiration dates and assist in relabeling as appropriate
  • Support in tracking all batch numbers used throughout trials and assist with preparation of appropriate CSR appendices
  • Provide vendor and budgets tracking and support
  • Manage and track US invoices for third party vendors
  • Updates Global ICF templates for all trials to ensure appropriate US standard language incorporated at time of package release while acting as the US liaison with Legal and the US sites through IRB approval process
  • Set up and maintain eTMF tracker for all studies
  • Provide support to ensure timely completion of eTMF tracker for CSR
  • Support in delegated aspects of trial data analysis and reporting, including attendance at all relevant study meetings (i.e. CTT and dose escalation meetings)
  • Provide support in meeting scheduling and distribution of meeting agendas/minutes
  • Assist with data monitoring such as tracking/filing of protocol deviations, generating data listings and database metrics
  • Assist with preparation and distribution of study tools needed at study start up and throughout trial as appropriate

Requirements:

  • Bachelor's Degree is required
  • At least 4 years of CTA experience from a pharmaceutical or CRO organization


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