Clinical Research Associate, Sponsor Dedicated, Oncology

IQVIA LLC; Overland Park (KS); On-site; USD 90,000 - 198,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate to oversee study sites, ensure GCP/ICH compliance, and contribute to advancing oncology research from Overland Park, Kansas.

In this role you’ll conduct site visits, train staff, manage TMF/ISF, monitor recruitment and data, and collaborate with the study team to drive project progress while maintaining strong relationships with clinical sites.

Qualifications

• BS degree in a scientific discipline or healthcare preferred.
• Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.
• Strong knowledge of GCP and ICH guidelines.

Responsibilities

• Perform site visits including selection, initiation, monitoring and close-out per GCP/ICH.
• Collaborate with sites to develop recruitment plans and track progress.
• Provide protocol training and maintain regular site communications.
• Evaluate site practices for protocol adherence and address quality issues.
• Monitor regulatory submissions, recruitment, enrollment, and data management.
• Maintain TMF and ISF documents per regulatory requirements.
• Mentor clinical staff through co-monitoring and training visits.
• Collaborate with study team to support project execution.
• Manage site finances and handle invoices per local requirements.

Skills

MS Office

Communication skills

Organizational skills

Problem-solving abilities

Education

BS Degree in scientific discipline or healthcare

Tools

Microsoft Office Suite

Job description

Role Overview

As a Clinical Research Associate, you’ll be at the forefront of ensuring our study sites operate smoothly and efficiently. Your work will be pivotal in advancing groundbreaking research.

Key Responsibilities

• Site Visits: Conduct selection, initiation, monitoring, and close-out visits, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Recruitment Drive: Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
• Training & Communication: Provide protocol training and maintain regular communication with sites to manage expectations and address issues.
• Quality Assurance: Evaluate site practices for protocol adherence and elevate quality issues as needed.
• Study Progress: Track regulatory submissions, recruitment, enrollment, and data management to ensure smooth study progress.
• Documentation: Maintain essential documents in the Trial Master File (TMF) and Investigator’s Site File (ISF) as per regulatory requirements.
• Mentorship: Mentor clinical staff through co-monitoring and training visits.
• Collaboration: Work closely with study team members to support project execution.
• Financial Management: Manage site finances and retrieve invoices as per local requirements.

Education

BS Degree in a scientific discipline or healthcare preferred.

Experience

Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.

Knowledge

Strong understanding of GCP and ICH guidelines, with expertise in oncology protocols.

Skills

Proficiency in Microsoft Office, excellent communication skills, and strong organizational and problem-solving abilities.

Attributes

Effective time and financial management, and the ability to build strong working relationships.

Why Join Us?

Be part of a team that’s driving innovation in clinical research. Your contributions will help shape the future of healthcare.

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.

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 $90,200.00 - $197,500.00. 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.