Sponsor-Focused Clinical Research Associate

IQVIA; Shenandoah (TX); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking a Clinical Site Monitor in the United States to perform site monitoring visits, ensure protocol compliance and data reporting, and support study management. You will work with sites to drive recruitment, provide protocol training, and track regulatory milestones.

The role requires at least 2 years of on-site monitoring experience, strong knowledge of GCP and ICH guidelines, and solid English communication, organizational, and time/financial management skills.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience required.
• Equivalent combination of education, training and experience may be accepted.
• Good knowledge of GCP and ICH guidelines.
• Proficiency with Word, Excel and PowerPoint; laptop and mobile devices usage.
• Strong written and verbal English communication.
• Excellent organizational, problem-solving and time/financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Coordinate recruitment plans to align with project needs and improve predictability.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, data queries; support startup as needed.
• Maintain TMF/ISF documentation per regulatory requirements.
• Create visit reports and follow-up letters; submit required study documentation.
• Collaborate with study team members for project execution support.
• May support site recruitment plans and site financial management where applicable.

Skills

On-site monitoring

GCP

ICH guidelines

English communication

Organizational skills

Problem-solving

Time management

Financial management

Relationship building

Team collaboration

Education

Bachelor's degree in scientific discipline or health care

Equivalent education/training/experience accepted

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Laptop usage

iPhone usage

iPad usage

Job description

IQVIA is seeking a Clinical Site Monitor in the United States to perform site monitoring visits, ensure protocol compliance and data reporting, and support study management. You will work with sites to drive recruitment, provide protocol training, and track regulatory milestones.

The role requires at least 2 years of on-site monitoring experience, strong knowledge of GCP and ICH guidelines, and solid English communication, organizational, and time/financial management skills.