On-Site Clinical Research Associate II

IQVIA; North Carolina; On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate II with independent on-site monitoring experience to join our team. You will monitor sites, train staff, and ensure compliance with GCP and ICH regulations across multiple therapeutic areas.

Responsibilities include site selection, initiation, routine monitoring, closeout visits, and TMF maintenance, with collaboration across cross-functional teams to achieve milestones and support patient recruitment at the site level.

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.
• Strong communication, organizational, and problem‑solving skills.
• 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 strong 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 accurately and are inspection-ready.
• Prepare monitoring reports, follow-up communications, and other required study documentation.
• Collaborate with cross-functional study teams to support successful project delivery and achieve study 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

Organizational skills

Problem-solving

Education

Bachelor's degree

Tools

Microsoft Office

Job description

IQVIA is seeking a Clinical Research Associate II with independent on-site monitoring experience to join our team. You will monitor sites, train staff, and ensure compliance with GCP and ICH regulations across multiple therapeutic areas.

Responsibilities include site selection, initiation, routine monitoring, closeout visits, and TMF maintenance, with collaboration across cross-functional teams to achieve milestones and support patient recruitment at the site level.