Clinical Research Associate — Site Monitoring & Oversight

IQVIA Inc

Durham (NC)

On-site

USD 72,000 - 189,000

Full time

6 days ago

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Job summary

IQVIA is seeking a Clinical Research Associate to monitor and manage site activities across studies, ensuring adherence to protocol, GCP and ICH guidelines. You will conduct site visits, train site staff, track recruitment, and maintain TMF/ISF documentation, collaborating with the study team to meet sponsor requirements and timelines.

The role requires at least 1 year of independent on-site monitoring experience, a science or healthcare degree, and strong communication in English.

Qualifications

Minimum 1 year of independent on-site CRA monitoring.
Bachelor's degree in science or healthcare preferred.
Strong knowledge of GCP/ICH guidelines.
Proficient in MS Word, Excel, PowerPoint.

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring and close-out) in accordance with scope and regulatory requirements (GCP/ICH).
Drive and track subject recruitment plans to align with project needs.
Administer protocol training and establish regular site communication to manage expectations and issues.
Evaluate site practices for protocol conduct and regulatory adherence; escalate quality issues as needed.
Track regulatory submissions, recruitment, CRF completion, data query resolution; support start-up phase if needed.
Maintain TMF/ISF documentation and site-related files.
Collaborate with study team for project execution support; assist in recruitment planning per site.