Sr. CRA 1 – Site Management

Overview

As a Senior CRA, you will lead site monitoring and site management to ensure studies run per protocol and regulations. You will collaborate with sites, manage recruitment planning, and maintain study documentation to support data integrity and regulatory compliance. This role sits in IQVIA’s Site Management team and offers opportunities to influence trial delivery and site performance. You will work with cross-functional teams to drive smooth project execution and impact patient outcomes. This role presents a meaningful chance to advance in clinical research within a global healthcare leader.

Responsibilities

• Conduct site visits (selection, initiation, monitoring, close-out) per scope of work and GCP
• Drive and track subject recruitment plans aligned with project needs
• Administer protocol training and maintain regular site communication
• Assess site practices for protocol adherence and regulatory compliance; escalate issues
• Track regulatory submissions, approvals, recruitment, CRF completion, and data query resolution; may support start-up
• Ensure TMF/ISF documents are complete and compliant with GCP/local rules
• Document site management activities and issues with visit reports and letters
• Collaborate with study team for project execution support
• Support development of site-specific recruitment plans where applicable
• Assist with site finance tasks and invoicing per clinical trial agreements where applicable

Key requirements

• Bachelor’s Degree in scientific discipline or health care (preferred)
• Minimum 2 years of on-site monitoring experience
• Solid knowledge of GCP and ICH guidelines
• Therapeutic and protocol knowledge provided by company training
• Proficient in Microsoft Word, Excel, PowerPoint; comfortable with laptops and mobile devices
• Strong written and spoken English communication
• Excellent organizational and problem-solving abilities
• Effective time and financial management skills
• Ability to build and maintain relationships with coworkers, managers, and clients

• strong communication
• organizational skills
• problem-solving
• GCP knowledge
• ICH guidelines
• Microsoft Word

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