Sponsor-Dedicated Clinical Research Associate

IQVIA; West Point (VA); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking an on-site Clinical Research Monitor to ensure sites conduct studies per protocol, GCP, and regulations. You will manage monitoring visits, regulatory submissions, and data quality while maintaining clear communication with site staff.

You will train sites, drive recruitment plans, and document findings in the TMF. Strong English skills and 2+ years of on-site experience are required.

Qualifications

• Bachelor's degree in a scientific discipline or health care (or equivalent).
• Minimum 2 years of on-site monitoring experience.
• Knowledge of GCP/ICH guidelines and applicable regulatory requirements.
• Strong written and verbal English communication skills.
• Proficient in MS Word/Excel/PowerPoint; familiarity with mobile devices if applicable.

Responsibilities

• Perform monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP.
• Collaborate with sites to drive subject recruitment plans and track progress.
• Administer protocol training to sites and maintain regular communication.
• Assess site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, and data queries.
• Maintain TMF/ISF documents and ensure regulatory filing readiness.
• Prepare visit reports and follow-up letters; document actions and outcomes.
• Coordinate with study team members for project execution support.

Skills

On-site monitoring

Communication

Time management

Teamwork

English proficiency

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Excel

PowerPoint

iPhone/iPad usage

Job description

IQVIA is seeking an on-site Clinical Research Monitor to ensure sites conduct studies per protocol, GCP, and regulations. You will manage monitoring visits, regulatory submissions, and data quality while maintaining clear communication with site staff.

You will train sites, drive recruitment plans, and document findings in the TMF. Strong English skills and 2+ years of on-site experience are required.