Clinical Site Coordinator - CTMS, TMF (Hybrid Bogotá)

Psi CRO; Bogotá ciudad; Híbrido; COP 44.640.000 - 78.120.000; Jornada completa

Descripción de la vacante

Psi CRO in Bogotá is seeking a Clinical Trial Administrator to support international clinical research projects. You will streamline communication, maintain systems, and manage documents and information.

Only CVs in English will be accepted. This hybrid role requires liaison with site personnel, vendors, and study sponsors, ensuring regulatory compliance and quality across CTMS/ISF processes.

Formación

• Life Sciences degree required.
• Administrative experience, preferably in international settings.
• Experience as CTA for CROs and in Clinical Research.
• Knowledge of local regulations.
• Full working proficiency in English.
• Proficient with MS Office applications.
• Ability to plan and work in a dynamic team environment.
• Strong communication and collaboration skills.

Responsabilidades

• Be the main point of contact between site personnel and CRA for query resolution and EDC completion.
• Serve as primary site contact for vendors, study supplies, and access management.
• Ensure pre-study testing (scans, qualification questionnaires, ECGs) is completed.
• Assist Monitors in CTMS data entry and track site issues in CTMS.
• Manage order, receipt, storage, distribution and recall of clinical supplies.
• Ensure regulatory submissions and ethics committee notifications are up to date.
• Coordinate site, TMF, and systems audits/inspections preparation.
• Manage TMF at site and country level; file ISF and ISF checklists.
• Arrange and track site training for vendor-related systems.
• Review document management and translation status of the study.
• Ensure proper safety information flow with investigative sites.

Conocimientos

MS Office

English

Teamwork

Educación

Life Sciences degree

Herramientas

CTMS

eTMF

Descripción del empleo

Psi CRO in Bogotá is seeking a Clinical Trial Administrator to support international clinical research projects. You will streamline communication, maintain systems, and manage documents and information.

Only CVs in English will be accepted. This hybrid role requires liaison with site personnel, vendors, and study sponsors, ensuring regulatory compliance and quality across CTMS/ISF processes.