Sponsor-Focused Clinical Research Associate (CRA)

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

Job summary

IQVIA is seeking a site monitoring professional to oversee conduct at study sites, ensuring data integrity and regulatory compliance. You will coordinate visits, training, and communication with sites to manage expectations and resolve issues.

Responsibilities include tracking regulatory submissions, CRF completion, recruitment progress, and maintaining essential study files. You may assist with start-up tasks and site-level financial management as needed.

Qualifications

• Bachelor's degree in scientific discipline or healthcare preferred.
• Requires at least 2 years of on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines.
• Written and verbal communication skills including good command of English.
• Proficiency in Microsoft Word, Excel, and PowerPoint; laptop and mobile devices usage.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Drive, adapt, and track subject recruitment plan to enhance predictability.
• Administer protocol training to sites and maintain regular communication to manage expectations and issues.
• Evaluate site practices for protocol adherence and regulatory compliance; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion, data query generation and resolution; support start-up phase.
• Maintain Trial Master File and Investigator's Site File following GCP/local requirements; file documents.
• Create and maintain documentation regarding site management, monitoring findings, and action plans with visit reports and follow-ups.
• Collaborate with study team members for project execution support.
• May support development of site recruitment plans and site financial management per agreement.

Skills

Site monitoring

Communication skills

Time management

Financial management

Team collaboration

English language

Education

Bachelor's Degree in scientific discipline or healthcare

Tools

Microsoft Word

Excel

PowerPoint

Laptop

iPhone

iPad

Job description

IQVIA is seeking a site monitoring professional to oversee conduct at study sites, ensuring data integrity and regulatory compliance. You will coordinate visits, training, and communication with sites to manage expectations and resolve issues.

Responsibilities include tracking regulatory submissions, CRF completion, recruitment progress, and maintaining essential study files. You may assist with start-up tasks and site-level financial management as needed.