On-Site Clinical Research Associate II

Regulatory Toolkit; Durham (NC); Sur place; USD 75 000 - 198 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Research Associate II with independent on-site monitoring experience to join our team. You will conduct site visits, train investigative sites, and monitor study progress in alignment with GCP/ICH regulations, ensuring TMF accuracy and inspection readiness.

Collaborate with cross-functional study teams, support patient recruitment and retention, and assist with site financial activities as needed.

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.

Responsabilités

• Conduct site selection, initiation, routine monitoring and closeout visits per GCP/ICH.
• Build relationships with investigative sites and provide training.
• Monitor progress including site activation, recruitment, enrollment, data collection, and query resolution.
• Evaluate site performance and escalate quality concerns.
• Ensure TMF and regulatory documentation are inspection-ready.

Connaissances

GCP knowledge

Communication skills

Organizational skills

Problem solving

Microsoft Office

Formation

Bachelor's degree

Outils

Microsoft Office

Description du poste

IQVIA is seeking a Clinical Research Associate II with independent on-site monitoring experience to join our team. You will conduct site visits, train investigative sites, and monitor study progress in alignment with GCP/ICH regulations, ensuring TMF accuracy and inspection readiness.

Collaborate with cross-functional study teams, support patient recruitment and retention, and assist with site financial activities as needed.