Sr. CRA, Sponsor Aligned, Oncology

IQVIA • Overland Park, KS

14d • $57,500 - $226,800

About The Position

Join our dynamic team as a Clinical Research Associate! You’ll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and sponsor requirements. Be at the forefront of groundbreaking cancer research and make a real impact on patients’ lives.

Requirements

• BS degree required; a degree in a scientific discipline or healthcare is preferred.
• 3+ years of on site oncology monitoring experience strongly preferred. 1.5+ years of oncology monitoring experience can be considered.
• Phase 1 oncology experience is required.
• Proficient in GCP and ICH guidelines.
• Strong therapeutic and protocol knowledge in Phase 1 oncology trials.
• Excellent computer skills, including Microsoft Office and mobile devices.
• Effective communication, organizational, and problem-solving abilities.
• Strong time management skills.
• Ability to build and maintain effective working relationships.

Responsibilities

• Site Monitoring Visits: Conduct selection, initiation, monitoring, and close-out visits in line with GCP and ICH guidelines.
• Subject Recruitment: Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
• Training & Communication: Provide protocol and study training to sites, maintaining regular communication to manage expectations and address issues.
• Quality Assurance: Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed.
• Study Progress Management: Oversee regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution. Support start-up phases as required.
• Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) per GCP/ICH and local regulations.
• Reporting: Generate visit reports, follow-up letters, and other necessary documentation.
• Mentorship: Mentor clinical staff through co-monitoring and training visits.
• Collaboration: Work closely with study team members to support project execution.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees