Senior Oncology CRA: Lead Clinical Site Monitoring

IQVIA; Durham (NC); On-site; USD 105,000 - 198,000; Full time

Job summary

IQVIA Biotech in Durham, NC is seeking a Senior Clinical Research Associate to independently monitor trial sites, ensure GCP/ICH compliance, and manage initiation, monitoring, and closeout visits. You will support site training and patient recruitment, and mentor junior CRAs as needed.

Requires 4+ years of on-site monitoring, strong knowledge of FDA regulations and trial processes, excellent organizational and communication skills, and the ability to manage multiple priorities in a fast-paced

Qualifications

• Bachelor’s degree in a scientific, healthcare, or related discipline (or equivalent).
• Minimum of 4 years of on-site clinical monitoring experience.
• Strong knowledge of GCP, ICH guidelines, FDA regulations, and trial processes.
• Experience conducting monitoring visits across multiple phases of clinical research.
• Excellent organizational, communication, and problem-solving skills.
• Ability to effectively manage multiple priorities in a fast-paced environment.
• Proficiency with Microsoft Office applications and clinical trial systems.

Responsibilities

• Independently manage and monitor clinical trial sites to ensure GCP/ICH compliance.
• Perform site qualification, initiation, routine monitoring, and closeout visits.
• Support patient recruitment/retention and provide protocol training.
• Oversee site performance, track milestones, resolve data queries, and maintain documentation.
• Mentor junior CRAs through co-monitoring and training activities.

Skills

GCP knowledge

ICH guidelines

FDA regulations

Clinical trial processes

Site monitoring

Microsoft Office

Multi-tasking

Communication

Education

Bachelor's degree in science/healthcare

Tools

Clinical trial systems

Job description

IQVIA Biotech in Durham, NC is seeking a Senior Clinical Research Associate to independently monitor trial sites, ensure GCP/ICH compliance, and manage initiation, monitoring, and closeout visits. You will support site training and patient recruitment, and mentor junior CRAs as needed.

Requires 4+ years of on-site monitoring, strong knowledge of FDA regulations and trial processes, excellent organizational and communication skills, and the ability to manage multiple priorities in a fast-paced