Senior CRA I — Onsite Monitoring Leader

IQVIA; Lisboa; In loco; EUR 40.000 - 58.000; Tempo pieno

Descrizione del lavoro

IQVIA in Portugal is seeking a Senior Clinical Research Associate I to oversee monitoring and site management for clinical studies, ensuring protocol adherence and data quality.

The role involves coordinating site visits, training site staff, tracking regulatory submissions, and maintaining TMF/ISF in line with GCP and local requirements. Strong communication, organizational, and Office skills are essential, with at least two years of on-site monitoring experience.

Competenze

• Bachelor's degree in a scientific discipline or healthcare field.
• Minimum 2 years of on-site monitoring experience.
• Good knowledge of applicable clinical research regulations, including ICH-GCP guidelines.
• Strong written and verbal English communication.

Mansioni

• Perform site monitoring visits (selection, initiation, monitoring, and close-out) per contract and GCP.
• Coordinate subject recruitment planning and site engagement.
• Provide protocol-related training and maintain regular site communication.
• Evaluate site practices for quality and regulatory compliance.
• Create and maintain monitoring documentation, visit reports, and action plans.
• Support start-up activities and TMF/ISF filing in line with regulations.

Conoscenze

On-site monitoring experience

Regulatory knowledge (ICH-GCP)

English communication

Project coordination

Microsoft Office

Time management

Financial management

Formazione

Bachelor's degree in a scientific discipline or healthcare field

Strumenti

Microsoft Word

Excel

PowerPoint

Descrizione del lavoro

IQVIA in Portugal is seeking a Senior Clinical Research Associate I to oversee monitoring and site management for clinical studies, ensuring protocol adherence and data quality.

The role involves coordinating site visits, training site staff, tracking regulatory submissions, and maintaining TMF/ISF in line with GCP and local requirements. Strong communication, organizational, and Office skills are essential, with at least two years of on-site monitoring experience.