Sponsor-Focused Clinical Research Associate

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

Job summary

IQVIA seeks a site monitoring professional to ensure sites conduct studies per protocol and regulatory guidelines. You will visit sites, train staff, and manage communications to support project expectations and issues.

You will monitor regulatory submissions, recruitment, and data queries, while maintaining necessary trial documents and collaborating with the study team to drive project success.

Qualifications

• Requires 2+ years of on-site monitoring experience.
• Bachelor's Degree in a scientific or health care field preferred.
• Good knowledge of GCP/ICH guidelines and regulatory requirements.
• Proficient in Microsoft Word, Excel and PowerPoint; able to use laptops and mobile devices.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Collaborate with sites to drive subject recruitment plans to meet project needs.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion, and data queries; support start-up phase if needed.
• Maintain TMF/ISF documentation and ensure regulatory filings are complete.
• Prepare visit reports, follow-up letters and related study documentation.
• Collaborate with study team to support project execution and site management.
• Possibly support site recruitment plans and site financial management per agreement.

Skills

Site monitoring

Regulatory knowledge

Communication skills

Time and financial management

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

iPhone/iPad usage

Job description

IQVIA seeks a site monitoring professional to ensure sites conduct studies per protocol and regulatory guidelines. You will visit sites, train staff, and manage communications to support project expectations and issues.

You will monitor regulatory submissions, recruitment, and data queries, while maintaining necessary trial documents and collaborating with the study team to drive project success.