Senior Clinical Research Associate I – Site Monitoring

IQVIA; Oeiras; Sur place; EUR 42 000 - 64 000; Plein temps

Résumé du poste

IQVIA is seeking a Senior Clinical Research Associate I to monitor and manage clinical sites, ensuring data quality and regulatory compliance across studies. You will conduct site visits, support start-up, and collaborate with study teams to drive successful execution.

Qualifications include a Bachelor’s in a scientific field and at least 2 years of on-site monitoring experience, with strong English communication and knowledge of ICH-GCP guidelines.

Qualifications

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

Responsabilités

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP.
• Drive subject recruitment plans in line with project needs.
• Administer protocol and site training and maintain regular communication with site personnel.
• Evaluate site practices for quality and protocol adherence; escalate issues.
• Track regulatory submissions, recruitment, CRFs, data queries, and resolutions.
• Support start-up activities and TMF/ISF maintenance per regulatory requirements.
• Create and maintain monitoring documentation, visit reports, and action plans.
• Collaborate with study team to support project execution.
• Support site-level recruitment planning and site financial management where applicable.

Connaissances

Site monitoring

GCP/ICH-GCP

Clinical research

Communication (English)

Formation

Bachelor’s degree in science/healthcare

Description du poste

IQVIA is seeking a Senior Clinical Research Associate I to monitor and manage clinical sites, ensuring data quality and regulatory compliance across studies. You will conduct site visits, support start-up, and collaborate with study teams to drive successful execution.

Qualifications include a Bachelor’s in a scientific field and at least 2 years of on-site monitoring experience, with strong English communication and knowledge of ICH-GCP guidelines.