Phase 1 Oncology CRA — Site Monitoring & Trial Leadership

IQVIA; Overland Park (KS); In loco; USD 72.000 - 189.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Clinical Research Associate to monitor oncology sites in Phase 1 trials, ensuring GCP/ICH compliance and managing site communications. You will support startup activities, patient recruitment, data quality, and regulatory submissions.

Ideal candidates hold a BS in a scientific discipline or healthcare, with 3+ years on-site oncology monitoring experience and strong time-management and problem-solving skills.

Competenze

• BS degree required; healthcare or scientific field preferred.
• 3+ years on-site oncology monitoring experience preferred.
• Phase 1 oncology experience required.
• GCP/ICH guidelines proficiency essential.

Mansioni

• Site monitoring visits including selection, initiation, monitoring, and close-out.
• Collaborate on subject recruitment and tracking plans.
• Provide protocol training and maintain site communication.
• Assess QA and regulatory compliance; escalate issues as needed.
• Manage study progress: regulatory submissions, CRF completion, data queries.
• Support startup phases and TMF/ISF documentation.
• Generate visit reports and follow-up correspondence.
• Mentor clinical staff through co-monitoring visits.
• Collaborate with study team to drive project execution.

Conoscenze

GCP/ICH knowledge

On-site monitoring

Phase 1 oncology

Communication

Organizational skills

Time management

Problem solving

Relationship building

Formazione

BS in science or healthcare

Strumenti

Microsoft Office

Mobile devices

Descrizione del lavoro

IQVIA is seeking a Clinical Research Associate to monitor oncology sites in Phase 1 trials, ensuring GCP/ICH compliance and managing site communications. You will support startup activities, patient recruitment, data quality, and regulatory submissions.

Ideal candidates hold a BS in a scientific discipline or healthcare, with 3+ years on-site oncology monitoring experience and strong time-management and problem-solving skills.