Sr. CRA, Sponsor Aligned, Oncology

Job Overview

• 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.
• Key
• 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.
• Qualifications
• Education: BS degree required; a degree in a scientific discipline or healthcare is preferred.

Experience

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.

Skills

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. Why Join Us? Be part of a team that’s pushing the boundaries of cancer research. You’ll have the opportunity to work on cutting-edge Phase 1 oncology trials, collaborate with top professionals in the field, and contribute to life-changing advancements in cancer treatment. If you’re passionate about making a difference and have the expertise we’re looking for, we’d love to hear from you! IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.