Onsite Clinical Research Monitor (CRA)

IQVIA; Aurora (CO); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA, a leading global provider of clinical research services, seeks a Clinical Research Associate to monitor and manage study sites across the US. You will ensure adherence to the protocol and regulatory requirements while coordinating site activities and training.

You will conduct visits, track enrollment, manage data queries, and maintain essential trial documentation. Strong communication and regulatory knowledge are essential for success.

Qualifications

• Bachelor's degree in a scientific or healthcare field is preferred.
• Minimum 2 years of on-site CRA monitoring experience in CRO, sponsor, or similar setting.
• Strong knowledge of GCP/ICH guidelines and regulatory requirements.

Responsibilities

• Perform monitoring visits (selection, initiation, on-site and close-out) per contract scope and GCP.
• Coordinate recruitment plans with sites to improve predictability and timelines.
• Administer protocol training and maintain regular communication with sites.
• Assess site practices for protocol adherence and regulatory compliance, escalating issues as needed.
• Track regulatory submissions, enrollment, CRF completion, data queries, and may support start-up phases.
• Maintain TMF/ISF documentation and ensure regulatory filing readiness.
• Create site-management documentation, visit reports, and follow-up communications.

Skills

CRA on-site monitoring

Regulatory knowledge

English communication

Time management

Financial management

Team collaboration

GCP/ICH familiarity

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Excel

PowerPoint

EDC

CTMS

eTMF

IVRS/IWRS

Job description

IQVIA, a leading global provider of clinical research services, seeks a Clinical Research Associate to monitor and manage study sites across the US. You will ensure adherence to the protocol and regulatory requirements while coordinating site activities and training.

You will conduct visits, track enrollment, manage data queries, and maintain essential trial documentation. Strong communication and regulatory knowledge are essential for success.