Sponsor-Centric Clinical Research Associate

IQVIA; Aurora (IL); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking an on-site Clinical Monitor to ensure study sites conduct the protocol as required and report data per sponsor guidelines. You will monitor visits, manage recruitment plans, deliver site training, and maintain regulatory documentation.

The role requires knowledge of GCP/ICH, strong English communication, and 2+ years of on-site monitoring experience. Proficiency in MS Office and data management is expected.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines.
• Proficiency in MS Word, Excel and PowerPoint.
• Written and verbal communication skills in English.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Work with sites to drive and track subject recruitment plan to enhance predictability.
• Administer protocol training to sites and establish regular communication about project expectations and issues.
• Evaluate quality and integrity of site practices for protocol conduct and regulatory adherence.
• Track regulatory submissions, recruitment/enrollment, CRF completion, data queries and resolutions; may support start-up phase.
• Ensure TMF and ISF documents are maintained per regulatory requirements; file site materials.
• Collaborate with study team for project execution support; assist development of recruitment plans per site.

Skills

GCP/ICH knowledge

English communication

MS Word

MS Excel

MS PowerPoint

Time management

Team collaboration

Problem solving

Education

Bachelor's degree in scientific discipline or healthcare

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

IQVIA is seeking an on-site Clinical Monitor to ensure study sites conduct the protocol as required and report data per sponsor guidelines. You will monitor visits, manage recruitment plans, deliver site training, and maintain regulatory documentation.

The role requires knowledge of GCP/ICH, strong English communication, and 2+ years of on-site monitoring experience. Proficiency in MS Office and data management is expected.