Clinical Research Associate II - Onsite Monitoring

IQVIA Inc; Durham (NC); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA Inc is seeking a Clinical Research Associate II with independent on-site monitoring experience to join our team. The candidate will monitor clinical studies across multiple therapeutic areas and ensure compliance with GCP/ICH regulations.

Responsibilities include site visits, training, monitoring progress, and collaboration with cross-functional teams to meet study milestones. Opportunities to support patient recruitment and site administration are available.

Qualifications

• Bachelor's degree required.
• Minimum 1 year of independent on-site monitoring experience in a CRO, biotech or pharmaceutical.
• Working knowledge of GCP, ICH, and clinical trial regulations.
• Proficiency with Microsoft Office applications.

Responsibilities

• Conduct site selection, initiation, routine monitoring, and closeout visits in accordance with GCP, ICH and applicable regulatory requirements.
• Build relationships with investigative sites and provide protocol, process, and study-specific training.
• Monitor study progress including site activation, patient recruitment, enrollment, data collection, and query resolution.
• Evaluate site performance and compliance, identifying risks and escalating quality concerns when appropriate.
• Ensure study documentation, regulatory records, and TMF requirements are maintained and inspection-ready.
• Prepare monitoring reports, follow-up communications, and other study documentation.
• Collaborate with cross-functional study teams to support project delivery and milestones.
• Support patient recruitment and retention initiatives at the site level.
• Assist with site financial and administrative activities, including invoice management when applicable.

Skills

Communication skills

Organizational skills

Problem-solving skills

Education

Bachelor's degree

Tools

Microsoft Office

Job description

IQVIA Inc is seeking a Clinical Research Associate II with independent on-site monitoring experience to join our team. The candidate will monitor clinical studies across multiple therapeutic areas and ensure compliance with GCP/ICH regulations.

Responsibilities include site visits, training, monitoring progress, and collaboration with cross-functional teams to meet study milestones. Opportunities to support patient recruitment and site administration are available.