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Senior Clinical Trial Administrator

hace 4 meses

Buenos Aires, Argentina PSI CRO A tiempo completo
Company Description


PSI 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 Description:


Join 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-Hybrid_

Qualifications:

  • College/University degree or an equivalent combination of education, training & experience;
  • Administrative work experience, preferably in an international setting;
  • Local regulations knowledge
  • Prior experience in Clinical Research;
  • Full working proficiency in English and Spanish;
  • Ability to plan and work in a dynamic team environment;
  • Communication and collaboration skills.
Additional Information


Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.