Sponsor-Dedicated CRA: Site Monitoring & Coordination

IQVIA; Linden (NJ); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA in the United States seeks a Site Monitoring professional to ensure study sites conduct and report data per protocol and regulations. You will perform visits, train sites, manage recruitment plans, and track regulatory submissions across assigned studies.

You will ensure TMF/ISF integrity, escalate quality issues, and collaborate with the study team to drive project execution and site performance. Strong English communication is essential.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Minimum of 2 years on-site monitoring experience.
• Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Proficiency in MS Word, Excel and PowerPoint; familiarity with laptops and mobile devices.
• Excellent written and verbal English communication.
• Strong organizational and problem-solving abilities.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Collaborate with sites to drive subject recruitment and track plan.
• Administer protocol and site training; maintain communication with sites.
• Evaluate site practices for protocol compliance and regulatory adherence.
• Manage study progress: regulatory submissions, recruitment, CRFs, data queries; support start-up.
• Maintain Trial Master File and ISF documentation.
• Create reports, follow-up letters and study documentation.
• Coordinate with study team for project execution.

Skills

On-site monitoring

GCP/ICH knowledge

English communication

Time management

Financial management

Team collaboration

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

IQVIA in the United States seeks a Site Monitoring professional to ensure study sites conduct and report data per protocol and regulations. You will perform visits, train sites, manage recruitment plans, and track regulatory submissions across assigned studies.

You will ensure TMF/ISF integrity, escalate quality issues, and collaborate with the study team to drive project execution and site performance. Strong English communication is essential.