Clinical Research Monitor: Site & Data Quality

IQVIA; Colorado Springs (CO); Vor Ort; USD 75.000 - 198.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Clinical Research Associate to perform on-site monitoring across study sites in accordance with protocol, GCP, and sponsor requirements. You will drive recruitment plans, administer protocol training, and maintain TMF/ISF documents while collaborating with the study team.

The role requires at least 2 years of CRA experience, strong regulatory knowledge, and fluency in English, with proficiency in EDC, CTMS, and eTMF systems to support monitoring activities.

Qualifikationen

• Bachelor's degree in a scientific field or healthcare preferred.
• At least 2 years of independent on-site monitoring experience as a CRA.
• Proficiency with clinical trial regulatory requirements (GCP/ICH).
• Experience using EDC, CTMS, eTMF and related trial systems.
• Strong written and verbal English communication; organizational skills.

Aufgaben

• Perform site monitoring visits (initiation, monitoring, close-out) per scope and GCP.
• Assist recruitment planning and track subject enrollment for project needs.
• Provide protocol training and maintain regular site communications.
• Ensure site documents are filed in TMF and ISF maintained per regs.
• Document monitoring findings, actions, and follow-up letters.
• Collaborate with study team for project execution and start-up support.

Kenntnisse

Clinical Research

On-site Monitoring

GCP/ICH Knowledge

Regulatory Compliance

Team Collaboration

Ausbildung

Bachelor's Degree in science or healthcare

Tools

EDC

CTMS

eTMF

IVRS/IWRS

Jobbeschreibung

IQVIA is seeking a Clinical Research Associate to perform on-site monitoring across study sites in accordance with protocol, GCP, and sponsor requirements. You will drive recruitment plans, administer protocol training, and maintain TMF/ISF documents while collaborating with the study team.

The role requires at least 2 years of CRA experience, strong regulatory knowledge, and fluency in English, with proficiency in EDC, CTMS, and eTMF systems to support monitoring activities.