Clinical Research Associate 2 (CRA II) – Oncology | IQVIA Full-Service
Location: Durham, North Carolina (Field-Based)
Additional Locations: Texas, Illinois, Remote (US), California, Ohio, Tennessee, Arizona, Indiana, Missouri, Colorado, Nevada, Kansas, Utah, Washington, North Carolina
Job Type: Full-Time
Job ID: R1492557
IQVIA is hiring a Clinical Research Associate 2 (CRA II) with strong experience in oncology clinical trials. This role supports full-service clinical operations and requires hands-on monitoring expertise to ensure the quality, integrity, and regulatory compliance of oncology studies.
Position Overview
The CRA II will manage on-site monitoring activities, ensure protocol adherence, and support study teams across multiple therapeutic oncology programs. This role is essential for maintaining high-quality clinical trial execution in accordance with GCP, ICH guidelines, and sponsor expectations.
Key Responsibilities
Clinical Monitoring
Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out visits.
Ensure monitoring activities align with contracted scope, Good Clinical Practice (GCP), and ICH regulations.
Recruitment and Site Support
Collaborate with site teams to develop and update subject recruitment strategies to improve enrollment predictability.
Provide protocol training and study-specific guidance to site staff.
Quality and Compliance Oversight
Assess adherence to protocol requirements, regulatory guidelines, and data quality standards.
Escalate quality or compliance concerns as appropriate.
Study Progress Management
Track regulatory submissions, approvals, subject enrollment, CRF completion, and data query resolution.
Provide support during study start-up as needed.
Documentation and File Maintenance
Ensure collection and filing of essential documents in the Trial Master File (TMF).
Verify proper maintenance of the Investigator Site File (ISF) per regulatory requirements.
Reporting and Communication
Prepare and submit detailed monitoring visit reports, follow-up letters, and documentation of action items.
Maintain continuous communication with study teams to support project execution.
Additional Responsibilities
Assist in developing site-level recruitment strategies when applicable.
Support site financial management, including tracking invoices and ensuring compliance with clinical trial agreements.
Required Qualifications
Education
Bachelor’s degree required.
Degree in a scientific discipline or healthcare field preferred.
Experience
Minimum 1.5 to 2 years of relevant clinical research experience.
At least 1.5 years of on-site oncology monitoring experience is mandatory.
Core Competencies
Strong understanding of GCP, ICH, and regulatory requirements.
Excellent organizational, analytical, and problem-solving skills.
Proficiency with Microsoft Office and clinical trial systems.
Ability to work independently and manage multiple site responsibilities.
Strong written and verbal communication skills.
Ability to travel based on project requirements.
Compensation
Annual base salary range: USD 87,200 – USD 189,000.
Actual compensation will depend on experience, location, and qualifications. Additional incentives, bonuses, and comprehensive health and welfare benefits may be available.
About IQVIA
IQVIA is a global leader in clinical research services, data analytics, and healthcare intelligence. The organization drives innovation in life sciences by integrating advanced technology with scientific expertise to accelerate the development and delivery of transformative medical treatments.
Equal Opportunity Statement
IQVIA is an equal opportunity employer. All qualified candidates will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected category.
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