CRA 2, Oncology, IQVIA Biotech

IQVIA LLC; Northern (KY); Hybrid; USD 75,000 - 175,000; Full time

Job summary

IQVIA Biotech is expanding our Clinical Monitoring team and seeks a CRA 2 with at least 1 year of on-site monitoring experience and oncology solid tumor exposure. The role emphasizes performing site visits, ensuring data integrity, and maintaining regulatory compliance across TMF/ISF.

You will collaborate with site staff, train personnel, track enrollments, and work with cross-functional teams to meet project timelines. Travel is required as needed.

Qualifications

• Bachelor’s degree in life sciences or health-related field or equivalent experience.
• Minimum of 1 year of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines and regulatory requirements.
• Ability to travel as required by the project.

Responsibilities

• Conduct all types of site visits—selection, initiation, monitoring, and close-out in line with scope, GCP and ICH.
• Collaborate with site staff to implement recruitment strategies aligned with timelines.
• Deliver protocol and study-specific training to site personnel and maintain communication.
• Assess site performance and ensure data integrity and protocol adherence.
• Monitor study progress via regulatory submissions, enrollment, CRFs, and data queries.
• Maintain essential documents in TMF and ISF per regulatory standards.
• Document site activities, visit outcomes, and follow-up actions with detailed reports.
• Work with cross-functional teams to support study execution and project goals.
• Support site-level recruitment planning and budget tracking as needed.

Skills

On-site monitoring

GCP & ICH

Regulatory knowledge

Travel flexibility

Education

Bachelor's degree in life sciences or health-related field

Job description

Job Overview

IQVIA Biotech is expanding our Clinical Monitoring team and is seeking CRA 2 professionals with a minimum of 1 year of on-site monitoring experience and oncology solid tumor monitoring experience. IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Key Responsibilities

• Conduct all types of site visits—selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
• Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
• Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
• Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
• Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
• Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
• Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
• Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
• Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.

Qualifications

• Bachelors degree in life sciences or health-related field (or equivalent experience).
• Requires at least 1 year of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Ability to travel as required by the project.

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 $74,500.00 - $175,100.00. 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.