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Clinical Trials Assistant

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Primary Location: Shah Alam, Selangor, Malaysia Full time R1234444

Job description

Job Responsibilities:
  • Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
  • Collaborate with Clinical Project Manager (CPM), CRS/iCRS, CRAs/iCRAs and RSU on 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 and completeness.
  • Collaborate with CRS/iCRS, CRAs/iCRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
  • Coordinate 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.
  • Assist in training and orienting new staff. May act as a mentor for less experienced CTAs
  • May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
  • Perform assigned administrative tasks to support team members with clinical trial execution.

Job Requirements:

  • Bachelors Degree in Pharmaceutical or related field
  • Min. 2 - 3 years of experience in clinical research environment
  • Open to candidates from non-clinical research environment but strong experience in administrative duties
  • 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

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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