Clinical Research Associate: Site Monitoring & Data Quality

IQVIA; Durham (NC); On-site; USD 90,000 - 190,000; Full time

Job summary

IQVIA is seeking a Site Monitor to ensure study sites conduct and report data per protocol, GCP, and sponsor requirements. You will perform monitoring visits, validate site activities, and manage regulatory submissions.

Strong communication and organization are essential for coordinating with sites and internal teams. The role emphasizes on-site monitoring, data integrity, and documentation, with potential involvement in site recruitment planning and startup activities.

Qualifications

• Bachelor's Degree in scientific discipline or health care.
• At least 1.5 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted.
• Good knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Proficiency with Microsoft Word, Excel and PowerPoint; able to use laptop and mobile devices.
• Strong written and verbal English communication; effective time and financial management.
• Ability to establish and maintain professional relationships with coworkers, managers and clients.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per contracted scope and GCP.
• Drive and track subject recruitment plans to improve predictability.
• Administer protocol training to sites and maintain communication about project expectations and issues.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate issues as needed.
• Track regulatory submissions, approvals, recruitment, CRF completion, and data query resolution; may support start-up.
• Ensure site documents and TMF/ISF are complete and compliant with regulatory requirements.
• Create and maintain site management documentation and visit reports; issue follow-up letters as required.
• Collaborate with study team for project execution support.
• May assist in developing recruitment plans per site; may handle site finance under the trial agreement.

Skills

English proficiency

Communication

Organizational skills

Problem solving

Time management

Financial management

Team collaboration

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

iPhone/iPad

Job description

IQVIA is seeking a Site Monitor to ensure study sites conduct and report data per protocol, GCP, and sponsor requirements. You will perform monitoring visits, validate site activities, and manage regulatory submissions.

Strong communication and organization are essential for coordinating with sites and internal teams. The role emphasizes on-site monitoring, data integrity, and documentation, with potential involvement in site recruitment planning and startup activities.