CRA 2, Oncology

About the role

IQVIA Biotech, a full-service CRO serving biotech sponsors, is expanding its Clinical Monitoring team and is looking for a CRA 2 with at least 1 year of on-site monitoring experience and oncology solid tumor monitoring experience. You will monitor and manage clinical sites so that trials run according to study protocols, regulatory requirements and sponsor expectations, contributing to the integrity and quality of clinical research data.

Key responsibilities

• Carry out site selection, initiation, monitoring and close-out visits in line with the contracted scope of work, GCP and ICH guidelines.
• Work with site staff to implement and track subject recruitment strategies aligned with project timelines and enrollment goals.
• Deliver protocol and study-specific training to site personnel and keep communication open to manage expectations and resolve issues.
• Assess site performance and adherence to the protocol, escalating quality concerns as needed.
• Track regulatory submissions, subject enrollment, CRF completion and resolution of data queries.
• Ensure documents are kept in the Trial Master File (TMF) and Investigator Site File (ISF) in line with regulatory standards.
• Document site management activities, visit outcomes and follow-up actions in reports and correspondence.
• Work with cross-functional project teams; depending on the project, support site-level recruitment planning, financial management, invoice collection and budget tracking.

Required profile

• 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 GCP, ICH guidelines and regulatory requirements.
• Ability to travel as required by the project.

What we offer

• Stated potential base pay range of $74,500 to $175,100 per year, depending on qualifications, location and schedule.
• Possible incentive plans, bonuses and other forms of compensation.
• Health and welfare benefits, depending on the position.