Clinical Research Associate: On-Site Monitoring Pro

IQVIA Inc; Colorado Springs (CO); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA Inc. is seeking a Clinical Research Associate to perform site monitoring and management across studies at our Colorado Springs site.

Responsibilities include site visits, recruitment tracking, training delivery, and ensuring regulatory compliance, TMF/ISF upkeep, and effective cross-team communication. Requires 2+ years on-site CRA experience and proficiency with EDC/CTMS/eTMF systems.

Qualifications

• Requires at least 2 years of on-site CR A experience in a CRO, sponsor or similar setting.
• Good knowledge of GCP and ICH guidelines.
• Proficient with MS Word, Excel and PowerPoint; able to use laptop, iPhone, iPad where applicable.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) per scope of work and Good Clinical Practice.
• Drive and track subject recruitment plans to align with project needs and improve predictability.
• Administer protocol and study training to sites and maintain regular communication to manage expectations and issues.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate quality issues as needed.
• Track regulatory submissions, approvals, recruitment, CRF completion, data query resolution; may support start-up phase.
• Ensure TMF and ISF documentation are maintained per GCP and regulatory requirements.
• Document site management findings and actions; submit visit reports and follow-up letters.

Skills

Communication skills

English proficiency

Organizational skills

Time management

Problem solving

Education

Bachelor's Degree in scientific discipline or healthcare

Tools

EDC

CTMS

eTMF

IVRS/IWRS

Job description

IQVIA Inc. is seeking a Clinical Research Associate to perform site monitoring and management across studies at our Colorado Springs site.

Responsibilities include site visits, recruitment tracking, training delivery, and ensuring regulatory compliance, TMF/ISF upkeep, and effective cross-team communication. Requires 2+ years on-site CRA experience and proficiency with EDC/CTMS/eTMF systems.