Senior CRA - Site Monitoring & Coordination

IQVIA LLC; Ciudad de México; Hybrid; MXN 350.000 - 520.000; Vollzeit

Zusammenfassung

IQVIA LLC is seeking an experienced SR CRA to perform site monitoring visits and manage regulatory alignment across multiple protocols and therapeutic areas in Mexico City. You will adapt and drive patient recruitment plans while maintaining open communication with sites and sponsors.

The role involves ensuring TMF/ISF compliance, training site staff, and collaborating with the study team to support project execution.

Qualifikationen

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 5 years of on-site monitoring experience, MINIMUM 1 year as a SR CRA.
• Familiar with Good Clinical Practice (GCP) and ICH guidelines.
• Strong communication in English and organizational skills.

Aufgaben

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope and regulatory requirements (GCP/ICH).
• Drive and track subject recruitment plans to align with project needs.
• Administer protocol training to sites and maintain regular communication with sites.
• Evaluate site practices for protocol adherence and regulatory compliance; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion, data queries, and project progress; support start-up if needed.
• Maintain TMF and ISF documentation per regulatory requirements; generate visit reports and follow-up letters.
• Mentor clinical staff through co-monitoring and training visits; collaborate with study team for project execution.
• Assist in developing recruitment plans and site financial management as applicable.

Kenntnisse

Site monitoring

GCP/ICH knowledge

English proficiency

Communication

Time management

Problem solving

Financial management

Team collaboration

Ausbildung

Bachelor's degree in science/healthcare

Tools

Excel

PowerPoint

Jobbeschreibung

IQVIA LLC is seeking an experienced SR CRA to perform site monitoring visits and manage regulatory alignment across multiple protocols and therapeutic areas in Mexico City. You will adapt and drive patient recruitment plans while maintaining open communication with sites and sponsors.

The role involves ensuring TMF/ISF compliance, training site staff, and collaborating with the study team to support project execution.