CRA 2, Oncology, IQVIA Biotech

CRA 2, Oncology, IQVIA Biotech

New York, United States of America | Field-based

IQVIA Biotech is expanding our Clinical Monitoring team and is seeking CRA 2 professionals with a minimum of 1 year of on-site monitoring experience and oncology solid tumor monitoring experience.

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Job Overview We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data.

Key Responsibilities

• Conduct all types of site visits—selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
• Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
• Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
• Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
• Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
• Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
• Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
• Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
• Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.

Qualifications

• Bachelor's degree in life sciences or health-related field (or equivalent experience).
• Requires at least 1 year of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Ability to travel as required by the project.

Where you'll work

Field-based

You'll work where the action is — out in the field, directly engaging with our customers, sites or partners. Field-based roles offer the opportunity to build relationships face-to-face, gain real-world insights and make a tangible impact.

Where you'll make an impact

IQVIA Biotech

At IQVIA Biotech, you'll support emerging and mid-sized biopharma companies in bringing innovative therapies to life. You'll work in a more agile, entrepreneurial environment while benefiting from IQVIA's global scale, helping advance clinical development with flexibility, speed and deep scientific expertise.