Sponsor-Focused Clinical Research Associate

IQVIA; San Jose (CA); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate (CRA) to monitor trial sites across assigned studies in accordance with GCP and regulatory requirements. You will coordinate with sites on initiation, monitoring, and close-out visits, while ensuring data quality and regulatory compliance.

The role requires 2+ years of on-site monitoring experience in a CRO or sponsor setting, strong English communication, and proficiency with EDC/CTMS/eTMF.

Qualifications

• Requires at least 2 years of independent on-site monitoring experience as a Clinical Research Associate (CRA) in a CRO, sponsor, or similar setting.
• Good knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Experience utilizing EDC, CTMS, eTMF, IVRS/IWRS, and other clinical trial systems.
• Written and verbal communication skills including good command of English language.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution.

Skills

English communication

Organizational skills

Time management

Client relationship management

Education

Bachelor's degree in scientific discipline or health care

Tools

EDC

CTMS

eTMF

IVRS/IWRS

Microsoft Word

Excel

PowerPoint

Job description

IQVIA is seeking a Clinical Research Associate (CRA) to monitor trial sites across assigned studies in accordance with GCP and regulatory requirements. You will coordinate with sites on initiation, monitoring, and close-out visits, while ensuring data quality and regulatory compliance.

The role requires 2+ years of on-site monitoring experience in a CRO or sponsor setting, strong English communication, and proficiency with EDC/CTMS/eTMF.