Clinical Research Site Coordinator I

PSI CRO; Buenos Aires; Presencial; ARS 48.292.000 - 78.474.000; Jornada completa

Descripción de la vacante

PSI CRO is seeking a results-driven Clinical Trial Support professional to join our international team in Argentina. You will act as the principal liaison between site staff and CROs, ensuring smooth query resolution and EDC completion.

You will manage vendor relations, study supplies, access controls, and regulatory submissions. The role requires experience in clinical research, strong English communication, and adept coordination of TMF and site documents across projects.

Formación

• Experience in coordinating clinical research projects or CTAs.
• Strong communication with sites, vendors and CROs.
• Familiarity with regulatory submissions and ethics approvals.
• Proficiency in English, both written and spoken.

Responsabilidades

• Be the main point of contact between site personnel and CRA for query resolution and EDC completion.
• Primary site contact for vendors, study supplies, and access management.
• Ensure pre-study testing (scans, qualification questionnaires, ECGs) is completed.
• Assist Monitors with CTMS data entry and track site issues in CTMS.
• Manage inventory, distribution, and reconciliation of clinical supplies.
• Ensure regulatory submissions and 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 training for site teams on vendor systems.
• Review document management and translation status.

Conocimientos

Administrative experience

CTA for CROs experience

Clinical research experience

English proficiency

MS Office proficiency

Teamwork & communication

Regulatory knowledge

Educación

College/University Degree in Life Sciences

Herramientas

MS Office

Descripción del empleo

PSI CRO is seeking a results-driven Clinical Trial Support professional to join our international team in Argentina. You will act as the principal liaison between site staff and CROs, ensuring smooth query resolution and EDC completion.

You will manage vendor relations, study supplies, access controls, and regulatory submissions. The role requires experience in clinical research, strong English communication, and adept coordination of TMF and site documents across projects.