Senior Clinical Research Associate, Sponsor Aligned, Oncology

IQVIA LLC; Overland Park (KS); On-site; USD 71,900 - 189,000; Full time

Job summary

IQVIA LLC is seeking a Sr. Clinical Research Associate to monitor and manage oncology clinical trial sites in Overland Park, KS. This role involves key responsibilities such as conducting site monitoring visits, ensuring compliance with regulations, and managing subject recruitment plans. Ideal candidates will have a BS degree and over 3 years of on-site oncology monitoring experience, with specific expertise in Phase 1 trials. Join us to contribute to innovative cancer research and make an impact on patient outcomes.

Qualifications

• 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.

Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits.
• Develop and track subject recruitment plans with sites.
• Provide protocol and study training to sites.
• Assess site practices for compliance and escalate issues.
• Oversee regulatory submissions, recruitment, and data completion.
• Ensure site documents are filed per GCP/ICH regulations.
• Generate visit reports and necessary documentation.
• Mentor clinical staff through training visits.

Skills

GCP and ICH guidelines

Oncology therapeutic knowledge

Microsoft Office proficiency

Effective communication

Organizational skills

Problem-solving abilities

Time management

Education

BS degree in scientific discipline or healthcare

Job description

Sr. CRA, Sponsor Aligned, Oncology page is loaded## Sr. CRA, Sponsor Aligned, Oncologylocations: Overland Park, KS, United States of America: Carlsbad, CA, United States of Americatime type: Full timeposted on: Posted Todayjob requisition id: R1541483Job 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.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 atIQVIA 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.