Clinical Research Associate, Sponsor Dedicated, Oncology

IQVIA; Overland Park (KS); Sur place; USD 90 000 - 198 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Research Associate to ensure study sites operate efficiently and in full regulatory compliance. You will perform site visits, support patient recruitment efforts, and provide protocol training while maintaining strong site relationships and rigorous data management.

With oncology experience, you will monitor progress, ensure TMF/ISF quality, and collaborate with study teams to drive successful trial execution in a fast-paced environment.

Qualifications

• 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.

Responsabilités

• Site Visits: Conduct selection, initiation, monitoring, and close-out visits, ensuring compliance with GCP and 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 TMF and 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.

Connaissances

Communication skills

Organizational skills

Problem-solving

Formation

BS degree in a scientific discipline or healthcare

Outils

Microsoft Office

Description du poste

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.

Qualifications

• 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.

About IQVIA

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

Equal Opportunity

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. https://jobs.iqvia.com/eoe

Integrity

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.

Compensation

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.

Company Culture

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

Thank you for your interest in growing your career with us.