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Clinical Trial Associate

New Jersey All, NJ

Post Date: 05/10/2018 Job ID: JN -052018-21549 Job Type: Clinical
  • Responsible for providing operational and program level support for several Phase I/II clinical trials
  • Support the group in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards
  • Assign 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
  • Set up and maintain 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
  • Manage 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
  • Supports activities including working closely with US Clinical Operations for US study start up meetings and trial agreements in addition to all other US based study start-up activities working closely with the US Clin Ops Oncology to ensure timely Study Initiations and VDR (Verification Document Receipt) support
  • Update Global ICF templates for all trials to ensure appropriate 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 in CREDI 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
  • Must Haves:
  • Minimum of 3 to 5 years of CTA experience from a pharma, biotech, and/or CRO company
  • BA/BS Degree is required
  • The ability to work in-house on a daily basis

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