Clinical Research Associate: Site Monitoring Pro

IQVIA; Abilene (TX); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA in the United States is seeking a Clinical Research Associate with on-site monitoring experience to ensure sites conduct studies per protocol, GCP, and regulatory requirements. The role involves coordinating recruitment plans, training sites, and tracking data integrity.

The candidate will manage site submissions, CRF completion, and data queries, while maintaining essential study documentation and fostering cross-functional collaboration with the study team.

Qualifications

• Minimum 2 years of independent on-site monitoring experience as a CRA.
• Knowledge of GCP and ICH guidelines.
• Experience with regulatory submissions and TMF/ISF practices.
• Proficient in Word, Excel, PowerPoint and clinical trial systems.

Responsibilities

• Perform site monitoring visits per scope of work and GCP.
• Collaborate with sites to manage recruitment and data collection.
• Train sites on protocol and study training requirements.
• Assess site adherence to regulatory requirements and escalate issues.
• Track regulatory submissions, enrollment, CRF completion and data queries.
• Maintain TMF/ISF documents and prepare visit reports.

Skills

CRA experience

GCP/ICH knowledge

English proficiency

Project coordination

Communication skills

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

EDC

CTMS

eTMF

IVRS/IWRS

Job description

IQVIA in the United States is seeking a Clinical Research Associate with on-site monitoring experience to ensure sites conduct studies per protocol, GCP, and regulatory requirements. The role involves coordinating recruitment plans, training sites, and tracking data integrity.

The candidate will manage site submissions, CRF completion, and data queries, while maintaining essential study documentation and fostering cross-functional collaboration with the study team.