Clinical Research Associate: Site Monitoring & Study Impact

IQVIA; West Point (VA); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking an on-site monitor in the United States to ensure sites conduct and report study data per protocol and guidelines. You will manage visits, training, document control and communications with sites to maintain quality and compliance across projects.

This role requires knowledge of GCP/ICH, strong English communication, and the ability to handle timelines, recruitment tracking and regulatory submissions while working with a cross-functional team.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted.
• Knowledge of GCP/ICH guidelines.
• Proficiency in MS Word, Excel, PowerPoint.
• Written and verbal communication in English.
• Organizational and problem-solving skills.
• Ability to establish and maintain effective working relationships.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) per scope of work and GCP.
• Work with sites to drive and track subject recruitment plan to meet project needs.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Track regulatory submissions, approvals, recruitment, CRF completion and data queries; may support start-up.
• Ensure site documents are filed in TMF and ISF maintained per regulatory requirements.
• Create and maintain site management documentation and visit reports.
• Collaborate with study team for project execution support.
• Support development of site recruitment plans and, if applicable, site financial management.

Skills

On-site monitoring

Regulatory knowledge

English communication

Education

Bachelor's degree in science/healthcare

Tools

Microsoft Word

Excel

PowerPoint

Laptop

iPhone/iPad

Job description

IQVIA is seeking an on-site monitor in the United States to ensure sites conduct and report study data per protocol and guidelines. You will manage visits, training, document control and communications with sites to maintain quality and compliance across projects.

This role requires knowledge of GCP/ICH, strong English communication, and the ability to handle timelines, recruitment tracking and regulatory submissions while working with a cross-functional team.