Sponsor‑Dedicated Clinical Research Associate

IQVIA; New City (NY); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA in the United States seeks a Site Monitoring Specialist to ensure study sites conduct visits and report data per the protocol, GCP, ICH guidelines, and sponsor requirements. This role requires residency in the U.S. and on-site work.

You will perform site monitoring visits (selection, initiation, ongoing monitoring, close-out), drive recruitment plans, administer protocol training, and maintain clear communication with sites to manage expectations and issues throughout the study lifecycle.

Qualifications

• Bachelor's Degree in scientific discipline or healthcare preferred.
• At least 2 years of on-site monitoring experience.
• Knowledge of GCP and ICH guidelines.
• Proficient in Microsoft Word, Excel and PowerPoint.
• Strong written and verbal English communication; organizational and time-management skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Drive subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol training to sites and maintain regular communication to manage expectations and issues.
• Evaluate site compliance with protocol and regulatory requirements; escalate as needed.
• Track regulatory submissions, recruitment, CRF completion, data queries, and TMF/ISF maintenance.

Skills

Site monitoring

GCP/ICH knowledge

Regulatory compliance

Client communication

Project coordination

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

IQVIA in the United States seeks a Site Monitoring Specialist to ensure study sites conduct visits and report data per the protocol, GCP, ICH guidelines, and sponsor requirements. This role requires residency in the U.S. and on-site work.

You will perform site monitoring visits (selection, initiation, ongoing monitoring, close-out), drive recruitment plans, administer protocol training, and maintain clear communication with sites to manage expectations and issues throughout the study lifecycle.