Clinical Trials Assistant
IQVIA
Makati City, Philippines
2d ago

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
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