Clinical Research Associate: Site Monitoring & Coordination

IQVIA Inc; Overland Park (KS); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA, a leading global provider of clinical research services, invites applications for an on-site Clinical Research Associate in the United States. You will perform site monitoring visits, ensure protocol adherence, manage recruitment plans, and maintain high-quality TMF documentation.

You will collaborate with study teams to track regulatory submissions, enrollments, CRFs, and data queries while applying GCP and ICH guidelines. Strong English communication and time management are essential.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 2 years of independent on-site monitoring experience as a CRA in a CRO, sponsor, or similar setting.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• Good clinical practice (GCP) and ICH guidelines.
• Proficiency with MS Word, Excel and PowerPoint; familiarity with laptops and mobile devices.
• Experience using EDC, CTMS, eTMF, IVRS/IWRS in monitoring activities.
• Strong written and verbal English communication; organizational and problem-solving skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Drive and track subject recruitment plans to enhance predictability.
• Administer protocol training to sites and maintain communication to manage expectations and issues.
• Evaluate site practices for protocol conduct and compliance with regulations; escalate issues.
• Track regulatory submissions, approvals, recruitment/enrollment, CRF completion and data queries; support start-up.
• Maintain TMF/ISF documentation and ensure regulatory filing compliance.
• Document site management, monitoring findings, and action plans with regular reports.

Skills

On-site monitoring

GCP knowledge

ICH guidelines

Regulatory requirements

English language

Project coordination

Communication skills

Time/financial management

Education

Bachelor's degree

Tools

EDC

CTMS

eTMF

IVRS/IWRS

Microsoft Word

Excel

PowerPoint

Job description

IQVIA, a leading global provider of clinical research services, invites applications for an on-site Clinical Research Associate in the United States. You will perform site monitoring visits, ensure protocol adherence, manage recruitment plans, and maintain high-quality TMF documentation.

You will collaborate with study teams to track regulatory submissions, enrollments, CRFs, and data queries while applying GCP and ICH guidelines. Strong English communication and time management are essential.