Sponsor-Dedicated Clinical Research Associate (CRA)

IQVIA; El Cajon (CA); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring professional to perform site monitoring visits, ensure protocol adherence, and support data reporting for studies conducted in the United States. You will manage site communications, training, and documentation to maintain regulatory compliance and quality.

The role requires on-site monitoring experience, knowledge of GCP/ICH guidelines, and strong English communication.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines.
• Proficiency with Word, Excel and PowerPoint; comfortable using mobile devices.
• Strong written and verbal English communication skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Collaborate with sites to drive and track subject recruitment plans.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, and data queries; support startup phase if needed.
• Maintain TMF and ISF documentation and ensure regulatory filing.
• Coordinate with study team and provide project execution support.
• Assist development of recruitment plans and, if applicable, site financial management.

Skills

English communication

Organizational skills

Time management

Problem-solving

Team collaboration

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

iPhone

iPad

Job description

IQVIA is seeking a Clinical Monitoring professional to perform site monitoring visits, ensure protocol adherence, and support data reporting for studies conducted in the United States. You will manage site communications, training, and documentation to maintain regulatory compliance and quality.

The role requires on-site monitoring experience, knowledge of GCP/ICH guidelines, and strong English communication.