Senior Clinical Research Associate, Sponsor Aligned, Oncology

IQVIA LLC; Overland Park (KS); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate to monitor oncology sites in Phase 1 trials, ensuring GCP/ICH compliance and managing site communications. You will support startup activities, patient recruitment, data quality, and regulatory submissions.

Ideal candidates hold a BS in a scientific discipline or healthcare, with 3+ years on-site oncology monitoring experience and strong time-management and problem-solving skills.

Qualifications

• BS degree required; healthcare or scientific field preferred.
• 3+ years on-site oncology monitoring experience preferred.
• Phase 1 oncology experience required.
• GCP/ICH guidelines proficiency essential.

Responsibilities

• Site monitoring visits including selection, initiation, monitoring, and close-out.
• Collaborate on subject recruitment and tracking plans.
• Provide protocol training and maintain site communication.
• Assess QA and regulatory compliance; escalate issues as needed.
• Manage study progress: regulatory submissions, CRF completion, data queries.
• Support startup phases and TMF/ISF documentation.
• Generate visit reports and follow-up correspondence.
• Mentor clinical staff through co-monitoring visits.
• Collaborate with study team to drive project execution.

Skills

GCP/ICH knowledge

On-site monitoring

Phase 1 oncology

Communication

Organizational skills

Time management

Problem solving

Relationship building

Education

BS in science or healthcare

Tools

Microsoft Office

Mobile devices

Job description

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.
• Experience: 1.5+ years of oncology monitoring experience can be considered.
• Phase 1 oncology experience is required.
• Skills: Proficient in GCP and ICH guidelines.
• Skills: Strong therapeutic and protocol knowledge in Phase 1 oncology trials.
• Skills: Excellent computer skills, including Microsoft Office and mobile devices.
• Skills: Effective communication, organizational, and problem-solving abilities.
• Skills: Strong time management skills.
• 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.

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 https://jobs.iqvia.com

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.