Clinical Research Associate II: On-Site Monitoring Specialist

Regulatory Toolkit; Durham (NC); 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 in Durham, North Carolina.

You will conduct visits, ensure GCP/ICH compliance, train sites, monitor enrollment and data, prepare reports, and collaborate with cross‑functional teams to keep studies on track. Experience in Immunology/GI, Dermatology, Women''s Health, Asthma/Respiratory, or Ophthalmology is a plus.

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 Trial Master File (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

Independent on-site monitoring

GCP/ICH knowledge

Communication skills

Microsoft Office

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 in Durham, North Carolina.

You will conduct visits, ensure GCP/ICH compliance, train sites, monitor enrollment and data, prepare reports, and collaborate with cross‑functional teams to keep studies on track. Experience in Immunology/GI, Dermatology, Women''s Health, Asthma/Respiratory, or Ophthalmology is a plus.