Oncology CRA II: Site Monitoring & Study Leadership

IQVIA; Durham (NC); Hybrid; USD 90,000 - 150,000; Full time

Job summary

IQVIA seeks a CRA 2 with on-site oncology monitoring experience to lead site visits and ensure GCP/ICH compliance. You will manage site communications, train sites on protocol requirements, and track recruitment and data quality across assigned studies.

Responsibilities include maintaining TMF/ISF readiness, coordinating regulatory submissions, and collaborating with cross-functional teams to keep projects on schedule. This on-site role is based in Durham, NC.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• 1.5–2 years of CRA experience including on-site monitoring.
• Knowledge of GCP/ICH guidelines.
• Strong communication and site management skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP/ICH.
• Drive subject recruitment plans in line with project needs.
• Administer protocol training and establish regular site communication.
• Evaluate site practices for protocol conduct and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, and data queries; support start-up if needed.
• Maintain TMF/ISF documentation and visit reports; escalate quality issues as needed.

Skills

Site monitoring

GCP/ICH knowledge

Communication

Education

Bachelor's degree in a scientific discipline or health care

Job description

IQVIA seeks a CRA 2 with on-site oncology monitoring experience to lead site visits and ensure GCP/ICH compliance. You will manage site communications, train sites on protocol requirements, and track recruitment and data quality across assigned studies.

Responsibilities include maintaining TMF/ISF readiness, coordinating regulatory submissions, and collaborating with cross-functional teams to keep projects on schedule. This on-site role is based in Durham, NC.