Sponsor-Focused Clinical Research Associate

IQVIA; Northfield (NJ); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking a Site Monitor to oversee study sites in New Jersey, ensuring data are reported per protocol and regulatory standards. You will conduct visits and coordinate with sites under GCP guidance.

Role requires at least 2 years of on-site monitoring, strong English communication, and solid knowledge of GCP/ICH guidelines. This position involves training sites, managing regulatory submissions, and maintaining TMF/ISF records.

Qualifications

• Requires at least 2 years on-site monitoring experience.
• Knowledge of GCP and ICH guidelines.
• Proficient in MS Office and clear communication.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs.
• Administer protocol and related study training to assigned sites and establish regular lines of communication.
• Evaluate site practices for quality and regulatory adherence; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion and data query resolution.

Skills

Site monitoring

English proficiency

GCP knowledge

Problem solving

Education

Bachelor's Degree

Tools

MS Word

MS Excel

PowerPoint

Job description

IQVIA is seeking a Site Monitor to oversee study sites in New Jersey, ensuring data are reported per protocol and regulatory standards. You will conduct visits and coordinate with sites under GCP guidance.

Role requires at least 2 years of on-site monitoring, strong English communication, and solid knowledge of GCP/ICH guidelines. This position involves training sites, managing regulatory submissions, and maintaining TMF/ISF records.