Clinical Research Associate — On-Site Monitoring & Site Management

IQVIA; Mount Vernon (IL); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate to monitor and manage site activities within the United States. The role focuses on ensuring sites conduct studies per protocol and regulatory requirements, with emphasis on monitoring visits, training, and data integrity.

The ideal candidate has 2+ years of CRA on-site experience, strong knowledge of GCP/ICH, and proficiency in common data systems (EDC/CTMS/eTMF/IVRS). Excellent English communication and project coordination skills are essential.

Qualifications

• Requires at least 2 years of independent on-site monitoring experience as a Clinical Research Associate (CRA).
• Good knowledge of GCP and ICH guidelines.
• Proficiency with Word, Excel and PowerPoint; familiarity with laptop, iPhone/iPad.
• Experience using EDC, CTMS, eTMF, IVRS/IWRS and other clinical trial systems.
• Excellent written and verbal English communication.
• Ability to manage timelines, budgets and relationships.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP.
• Collaborate with sites to recruit subjects and track recruitment.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, approvals, recruitment, CRF completion, data queries.
• Maintain TMF/ISF documentation.
• Create site management docs and regular visit reports.
• Collaborate with study team for project execution.
• Support recruitment plans per site.
• Possibly support site financial management and invoicing.

Skills

Good communication

Organizational skills

Time management

Problem-solving

Financial management

English language

Education

Bachelor's degree in scientific discipline or health care

Tools

EDC

CTMS

eTMF

IVRS/IWRS

MS Word

MS Excel

PowerPoint

Job description

IQVIA is seeking a Clinical Research Associate to monitor and manage site activities within the United States. The role focuses on ensuring sites conduct studies per protocol and regulatory requirements, with emphasis on monitoring visits, training, and data integrity.

The ideal candidate has 2+ years of CRA on-site experience, strong knowledge of GCP/ICH, and proficiency in common data systems (EDC/CTMS/eTMF/IVRS). Excellent English communication and project coordination skills are essential.