Senior Clinical Research Associate — Trials Lead

Santex; Quilmes; Sur place; ARS 900 000 - 1 400 000; Plein temps

Résumé du poste

Santex is seeking a Senior Clinical Research Associate to oversee planning, execution, and management of clinical trials in Buenos Aires, Argentina. The role emphasizes data integrity, regulatory compliance, and collaboration across teams.

The candidate should bring at least 4 years of on-site monitoring experience, strong English skills, and deep knowledge of GCP/ICH guidelines. Travel willingness is required as part of the job responsibilities.

Qualifications

• Bachelor's degree in health care or scientific discipline.
• At least 4 years of on-site monitoring experience.
• Advanced English.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Proficiency in CTMS and EDC systems.
• Willingness to travel as required.

Responsabilités

• Perform site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation.
• Support the development of a subject recruitment plan.
• Establishing regular lines of communication plus administering protocol and related study training to assigned sites.
• Evaluating the quality and integrity of site practices - escalating quality issues as appropriate.
• Managing progress by tracking regulatory submissions, recruitment, data query resolution.
• Comfortably collaborating and communicating with a variety of colleagues and customers; good knowledge of applicable clinical research regulatory requirements.

Connaissances

On-site monitoring

Advanced English

GCP/ICH knowledge

Regulatory requirements

CTMS proficiency

EDC proficiency

Formation

Bachelor's degree in health care or scientific discipline

Outils

CTMS

EDC

Description du poste

Santex is seeking a Senior Clinical Research Associate to oversee planning, execution, and management of clinical trials in Buenos Aires, Argentina. The role emphasizes data integrity, regulatory compliance, and collaboration across teams.

The candidate should bring at least 4 years of on-site monitoring experience, strong English skills, and deep knowledge of GCP/ICH guidelines. Travel willingness is required as part of the job responsibilities.