Oncology CRA II — Site Monitoring & Study Delivery

Regulatory Jobs; Durham (NC); On-site; USD 90,000 - 150,000; Full time

Job summary

IQVIA is seeking a CRA II with 1.5–2 years of on-site oncology monitoring experience in the United States. The role focuses on site monitoring visits, GCP/ICH compliance, and active collaboration with sites to maintain high study quality.

Responsibilities include recruitment planning, protocol training, regulatory submissions tracking, and TMF/ISF management. Bachelor's degree in a scientific field or healthcare is preferred, with potential for start-up support as needed.

Qualifications

• 1.5 to 2 years of CRA experience including on-site monitoring.
• Bachelor’s Degree in scientific discipline or health care preferred.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per contracted scope and GCP/ICH guidelines.
• Drive and track subject recruitment plans to meet project needs.
• Administer protocol training to sites and maintain regular communication to manage expectations and issues.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate issues as needed.
• Manage progress by tracking regulatory submissions, approvals, recruitment, CRF completion and data queries; support start-up as needed.
• Ensure TMF/ISF documentation is complete and filed per regulatory requirements.
• Collaborate with study team members for project execution and site management.

Skills

Site monitoring

GCP/ICH compliance

Recruitment planning

Documentation

TMF/ISF management

Regulatory submissions

Education

Bachelor’s Degree in scientific discipline or healthcare

Job description

IQVIA is seeking a CRA II with 1.5–2 years of on-site oncology monitoring experience in the United States. The role focuses on site monitoring visits, GCP/ICH compliance, and active collaboration with sites to maintain high study quality.

Responsibilities include recruitment planning, protocol training, regulatory submissions tracking, and TMF/ISF management. Bachelor's degree in a scientific field or healthcare is preferred, with potential for start-up support as needed.