Clinical Trials Assistant

3 weeks ago


Singapore Iqvia Rds East Asia Pte. Ltd. Full time

Responsibilities

  • 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.

Job Requirements:

  • Bachelors Degree in Pharmaceutical or related field
  • Min. 1-3 years of experience in clinical research environment
  • Basic knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Broad knowledge of applicable protocol requirements as provided in company training
  • Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
  • Good 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


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