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.

Key responsibilities

• Carry out site selection, initiation, monitoring and close-out visits in line with the contracted scope, GCP and ICH guidelines
• Work with site staff on subject recruitment strategies and track enrollment against project timelines
• Deliver protocol and study-specific training to site personnel and keep them informed
• Assess site performance and escalate quality concerns to protect data integrity
• Track regulatory submissions, enrollment, CRF completion and data query resolution
• Maintain documents in the Trial Master File (TMF) and Investigator Site File (ISF)
• Document site management activities, visit outcomes and follow-ups in reports and correspondence
• Support cross-functional project teams; depending on the project, also support recruitment planning, 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 annualized base pay range of $74,500 to $175,100, which may vary with qualifications, location and schedule
• Possible incentive plans, bonuses and other compensation depending on the position
• Health and welfare benefits and other benefits depending on the position