Clinical Research Associate — Site Monitoring & Coordination

IQVIA Argentina; Northern (KY); Hybrid; USD 87,000 - 182,000; Full time

Job summary

IQVIA in the United States is seeking a site monitoring professional to ensure sites conduct the study per protocol, regulations, and sponsor requirements. This role emphasizes on-site visits and collaboration with study teams.

Responsibilities include monitoring visits, recruitment planning, training sites, and maintaining TMF/ISF accuracy while upholding GCP/ICH standards. Strong English communication, organizational and time-management skills are essential.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 1.5 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• GCP and ICH guidelines knowledge.
• Proficiency in Word, Excel and PowerPoint; laptop and mobile devices.
• Written and verbal communication skills in English.
• Organizational and problem-solving skills.
• Effective time and financial management; ability to build relationships.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) per scope and GCP.
• Drive and track subject recruitment plans to align with project needs.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion and data queries.
• Ensure TMF and ISF documents are maintained per regulations.
• Create visit reports and follow-up letters; collaborate with study team.

Skills

English communication

Organizational skills

Problem-solving

Time management

Financial management

Team collaboration

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Laptop computer

iPhone

iPad

Job description

IQVIA in the United States is seeking a site monitoring professional to ensure sites conduct the study per protocol, regulations, and sponsor requirements. This role emphasizes on-site visits and collaboration with study teams.

Responsibilities include monitoring visits, recruitment planning, training sites, and maintaining TMF/ISF accuracy while upholding GCP/ICH standards. Strong English communication, organizational and time-management skills are essential.