CRA, Early Development — On-Site Monitoring

IQVIA; Carlsbad (CA); On-site; USD 90,000 - 175,000; Full time

Job summary

IQVIA in the United States is seeking a dedicated Clinical Research Associate (CRA) to monitor and manage clinical sites, ensuring protocol adherence, regulatory compliance, and sponsor expectations. Your work will contribute to data integrity.

You will conduct site visits (selection, initiation, monitoring, close-out) per GCP/ICH guidelines, support subject recruitment, provide protocol training, and collaborate with cross-functional teams to ensure study goals are met.

Qualifications

• Requires a Bachelor’s degree in life sciences or a health-related field.
• Minimum 1.5 years of on-site monitoring experience.
• Solid understanding of GCP, ICH guidelines, and regulatory requirements.

Responsibilities

• Monitor clinical sites and manage activities to ensure protocol compliance and data integrity.
• Conduct site visits (selection, initiation, monitoring, close-out) per GCP/ICH.
• Collaborate with site staff to support subject recruitment and enrollment goals.
• Provide protocol training to site personnel and maintain clear communication with sponsors.
• Track regulatory submissions, CRFs, and data queries to ensure study progress.
• Maintain TMF/ISF documentation and prepare site management reports.
• Support cross-functional project teams to align with study goals.
• Assist with site-level recruitment planning and budget tracking where applicable.

Skills

GCP knowledge

ICH guidelines understanding

Regulatory requirements awareness

Education

Bachelor's degree in life sciences or health-related field

Job description

IQVIA in the United States is seeking a dedicated Clinical Research Associate (CRA) to monitor and manage clinical sites, ensuring protocol adherence, regulatory compliance, and sponsor expectations. Your work will contribute to data integrity.

You will conduct site visits (selection, initiation, monitoring, close-out) per GCP/ICH guidelines, support subject recruitment, provide protocol training, and collaborate with cross-functional teams to ensure study goals are met.