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Contract Trial Master File

Lake Forest, Illinois 60045

Post Date: 04/13/2018 Job ID: 1914 Job Category: Clinical: Quality

Job Responsibilities:
  • QC and reconcile available electronic and paper files from one or more Trial Master Files and document deficiencies
  • Create inventory of documents on hand TMFs and identify and document   gap(s)
  • Maintain the TMFs according to applicable   SOPs Provide document tracker or listing for Clinical Trial Monitors to assist in document reconciliation and retrieval from clinical sites
  • Provide the study team updates on TMF status
  • Contact clinical sites as directed to obtain documents
  • Primary point of contact for internal study teams to ensure document quality requirements and timelines are met


Qualifications/ Requirements:
  • Bachelor' s degree or equivalent
  • Clinical documentation management and industry experience of at least 2 years; TMF audit experience a plus
  • Experience/knowledge of ICH/GCP, US 21 CFR, and FDA BIMO   documentation requirements
  • Ability to quickly adapt to systems and technology
  • Ability to travel domestically as needed
  • Willingness to work in-house 5 days/week
  • Position not to exceed 40 hrs./week.

Anna Korelis

Anna is a creative problem solver who prides herself on her strong work ethic and expert communication skills. Goal-oriented and service-driven, Anna has a keen eye for the skills that enable her candidates to stand out, and digs deep to understand what motivates them to find their next opportunity.

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