Clinical Trial Administrator II
PSI CRO
- Buenos Aires
- Permanente
- Tiempo completo
- 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.
- 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 Spanish;
- Proficiency in MS Office applications;
- Ability to plan and work in a dynamic team environment;
- Communication and collaboration skills.