Clinical Research Associate: Site Monitoring & Study Delivery

IQVIA; Gloucester (VA); Vor Ort; USD 75.000 - 195.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Clinical Research Associate to monitor and manage study sites, ensuring compliance with the protocol, GCP, and regulatory requirements. You will perform site visits, support recruitment plans, and maintain clear communication with sites and sponsor.

The role requires 2+ years of on-site CRA experience, proficiency with EDC/CTMS/eTMF, and strong organizational and problem-solving skills. Collaboration with the study team is essential to ensure data quality and study success.

Qualifikationen

• 2+ years of on-site monitoring experience as CRA in CRO or sponsor.
• Strong knowledge of GCP/ICH guidelines.
• Experience with clinical trial systems (EDC/CTMS/eTMF).
• Proficient in English with strong communication.

Aufgaben

• Perform site monitoring visits per scope of work and GCP.
• Coordinate site recruitment and track plans.
• Administer protocol training and maintain site communications.
• Manage regulatory submissions, approvals, and data query resolution.
• Ensure TMF/ISF documentation and site files.
• Collaborate with study team for project execution.

Kenntnisse

GCP/ICH

EDC/CTMS/eTMF

Regulatory knowledge

English communication

MS Office

Time management

Relationship management

Ausbildung

Bachelors in science or health care

Tools

EDC

CTMS

eTMF

IVRS/IWRS

Microsoft Office

Jobbeschreibung

IQVIA is seeking a Clinical Research Associate to monitor and manage study sites, ensuring compliance with the protocol, GCP, and regulatory requirements. You will perform site visits, support recruitment plans, and maintain clear communication with sites and sponsor.

The role requires 2+ years of on-site CRA experience, proficiency with EDC/CTMS/eTMF, and strong organizational and problem-solving skills. Collaboration with the study team is essential to ensure data quality and study success.