Clinical Trial Administrator Ii

hace 5 meses


Bogota, Colombia 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-Remote_

**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.



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