Clinical Research Associate - Site Monitoring

IQVIA; Chicago (IL); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking a Site Monitoring Specialist to ensure that study sites conduct the study per protocol, ICH/GCP guidelines, and sponsor requirements in the United States. You will perform site monitoring visits, support site training, manage recruitment plans, and maintain TMF/ISF documentation while collaborating with project teams to meet study milestones and ensure quality and compliance.

This role emphasizes strong communication skills, time and financial management, and the ability to

Qualifications

• Bachelor's Degree in scientific discipline or healthcare preferred.
• Requires at least 2 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Therapeutic and protocol knowledge as provided in company training.
• Proficient in Microsoft Word, Excel and PowerPoint; able to use a laptop and mobile devices.
• Excellent written and verbal communication in English.
• Strong organizational and problem-solving abilities.
• Effective time and financial management skills.
• Ability to establish and maintain productive working relationships with colleagues, managers, and clients.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope of work and GCP.
• Collaborate with sites to drive and track subject recruitment as needed.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol compliance and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion, data queries; support start-up phases.
• Ensure site documents are filed in TMF and ISF is maintained per regulatory requirements.
• Create and maintain site management documentation and visit reports.
• Coordinate with study team members for project execution support.
• Support development of site recruitment plans and, if applicable, site financial management.

Skills

On-site monitoring

GCP/ICH knowledge

English communication

Time management

Financial management

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Laptop

iPhone

iPad

Job description

IQVIA is seeking a Site Monitoring Specialist to ensure that study sites conduct the study per protocol, ICH/GCP guidelines, and sponsor requirements in the United States. You will perform site monitoring visits, support site training, manage recruitment plans, and maintain TMF/ISF documentation while collaborating with project teams to meet study milestones and ensure quality and compliance.

This role emphasizes strong communication skills, time and financial management, and the ability to