Global Clinical Trials Site Coordinator

PSI CRO; Región Metropolitana de Santiago; Presencial; CLP 13.392.000 - 20.088.000; Jornada completa

Descripción de la vacante

PSI CRO Chile is seeking a dedicated Clinical Trial Assistant to support site personnel and CRA teams, handling documentation, queries, and EDC tasks to keep studies on track.

The role requires a life sciences degree, CTA experience in CROs, strong English, and proficiency with MS Office; you will coordinate regulatory submissions and TMF files.

Join our international research team and grow in clinical trials while contributing to high-quality study management.

Formación

• College/University Degree in Life Sciences.
• Administrative work experience, preferably in an international settings.
• Prior experience working as CTA for CROs.
• Prior experience working in Clinical Research.
• Local regulations knowledge.
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to plan and work in a dynamic team environment.
• Communication and collaboration skills.

Responsabilidades

• Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion.
• Serves as the primary sites’ contact point for vendors, study supplies, and access management.
• Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed.
• Assists the Monitors in their prompt completion of all subject event and site event information in CTMS. Track the resolution status of site issues and action items in CTMS.
• Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
• Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions.
• Coordinate preparation for and follow-up on site, TMF and systems´ audits and inspections.
• Manage the TMF on a site and a country level for regularly and filedocuments. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
• Arrange and track initial and on-going project training for site teams in all vendor-related systems.
• Document Management and translations status review of the study.
• Ensures proper safety information flow with investigative sites.

Conocimientos

Communication skills

Team collaboration

English proficiency

Educación

College/University Degree in Life Sciences

Herramientas

MS Office

Descripción del empleo

PSI CRO Chile is seeking a dedicated Clinical Trial Assistant to support site personnel and CRA teams, handling documentation, queries, and EDC tasks to keep studies on track.

The role requires a life sciences degree, CTA experience in CROs, strong English, and proficiency with MS Office; you will coordinate regulatory submissions and TMF files.

Join our international research team and grow in clinical trials while contributing to high-quality study management.