Clinical Trial Administrator II

PSI CRO

  • São Paulo - SP
  • Permanente
  • Período integral
  • Há 16 dias
  • Aplicar facilmente
Company DescriptionPSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionJoin our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.Only CVs in English will be accepted.You will be responsible for:
  • Customization of Site ICF/patient documents before sending it to sites;
  • EC- IRB submissions;
  • Site Room, Veeva Vault, electronic Trial Master file and CTMs (including set up and maintenance);
  • Site file preparation for SIV (Printing and assembling documents);
  • Collection and filing documents from sites for MOH submissions;
  • Coordinate the translation of documents;
  • Collection/QC/filing of site documents– all documents required per Data Management Plan, not limited to Investigational Product Release-Enabling Document;
  • Accesses to systems: Collecting vendor access information from sites in the format requested.
#LI-HybridQualifications
  • College/University degree or an equivalent combination of education, training & experience;
  • Minimum 1 year of industry experience
  • Administrative work experience, preferably in an international setting;
  • Local regulations knowledge;
  • Prior experience in Clinical Research;
  • Full working proficiency in English and Portuguese;
  • Proficiency in MS Office applications;
  • Ability to plan and work in a dynamic team environment;
  • Communication and collaboration skills.
Additional InformationAdvance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.

PSI CRO