Clinical Trial Administrator II

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. 

Hybrid position in Buenos Aires, Argentina

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;
• 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.

Additional Information

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