Oncology CRA II — Site Monitoring & Trial Delivery

IQVIA Inc; Carlsbad (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

IQVIA is seeking a CRA II with at least 1.5 years of on-site oncology monitoring experience. You will perform site visits, manage recruitment plans, and train site staff while ensuring compliance with GCP and ICH guidelines.

Responsibilities include monitoring, data query resolution, and TMF/ISF maintenance, with potential involvement in start-up activities and site finance management as needed. This role requires strong communication with site staff and the study team.

Qualifications

• 1.5 to 2 years of CRA experience including on-site monitoring.
• Bachelor’s degree (scientific discipline or health care preferred).
• GCP/ICH regulatory requirements knowledge.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with contracted scope and GCP/ICH guidelines.
• Drive subject recruitment plans with sites to improve predictability and progress.
• 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.
• Track regulatory submissions, recruitment/enrollment, CRF completion, data queries; may support start-up.
• Ensure site documents are filed in TMF and ISF is maintained per local requirements.
• Create and maintain site management documentation including visit reports and follow-up letters.
• Collaborate with study team for project execution and support.
• May support site financial management and invoicing per the clinical trial agreement.

Skills

On-site monitoring

GCP/ICH knowledge

Communication skills

Clinical research

Education

Bachelor's degree in scientific discipline or health care

Job description

IQVIA is seeking a CRA II with at least 1.5 years of on-site oncology monitoring experience. You will perform site visits, manage recruitment plans, and train site staff while ensuring compliance with GCP and ICH guidelines.

Responsibilities include monitoring, data query resolution, and TMF/ISF maintenance, with potential involvement in start-up activities and site finance management as needed. This role requires strong communication with site staff and the study team.