Clinical Trials Assistant
IQVIA
São Paulo, Brazil
há 1 dia

Job Overview

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

  • Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.
  • g., Trial Master File (TMF)) that track site compliance and performance within project timelines.

  • Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
  • Assist with periodic review of study files for completeness.
  • Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
  • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
  • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
  • May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
  • Qualifications

  • High School Diploma or equivalent Req
  • Equivalent combination of education, training and experience.
  • Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
  • Written and verbal communication skills including good command of English language.
  • Effective time management and organizational skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  • Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
  • Knowledge of applicable protocol requirements as provided in company training.
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