CRA 2, Oncology, IQVIA Biotech - Full-time

Position Overview

IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring experience and oncology monitoring expertise. 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 to help bring breakthrough treatments to patients faster. We are seeking a dedicated Clinical Research Associate (CRA) to ensure the successful execution of clinical trials, managing clinical sites to maintain compliance with study protocols, regulatory requirements, and sponsor expectations.

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) per 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.
• Support site-level recruitment planning and financial management, including invoice collection and budget tracking where applicable.

Required Qualifications

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

Benefits & Perks

• Compensation Range: $69,800.00 - $226,800.00 per annum. The actual base pay may vary based on qualifications, experience, location, and work schedule (full or part-time).
• Dependent on the position offered, incentive plans, bonuses, and other compensation forms may be provided.
• A comprehensive range of health, welfare, and other employee benefits is available.
• IQVIA is an equal opportunity employer offering consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.