Phase I CRA – Early Clinical Development

IQVIA

Atlanta (GA)

Sur place

USD 90 000 - 175 000

Plein temps

14 jours+

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Résumé du poste

IQVIA is now hiring a Clinical Research Associate (CRA) to join our Early Clinical Development team, focusing on Phase I trials across the West and East Coasts of the United States. You will monitor sites and ensure protocol adherence to regulatory requirements, contributing to data integrity.

The role requires on-site monitoring experience, strong knowledge of GCP/ICH, and willingness to travel as projects demand.

Qualifications

Bachelor’s degree in life sciences or health-related field, or equivalent experience.
At least 1.5 years of on-site monitoring experience.
Strong understanding of GCP, ICH guidelines, and regulatory requirements.
Willingness and ability to travel as required by the project.

Responsabilités

Conduct site visits: selection, initiation, monitoring, and close-out per GCP/ICH.
Collaborate with site staff to support subject recruitment and enrollment goals.
Deliver protocol training to site personnel and maintain clear communication.
Assess site performance and ensure adherence to study protocol and data integrity.
Monitor progress: regulatory submissions, enrollment, CRF completion, data queries.
Maintain TMF/ISF documentation in line with regulatory standards.
Document site activities and follow-up actions with detailed reports.
Work with cross-functional teams to support study execution.
Assist with site-level recruitment planning and budget tracking when needed.