CRA 2 - Oncology, U.S. East Coast, Central or West Coast

IQVIA; Chicago (IL); On-site; USD 69,000 - 227,000; Full time

Job summary

An established industry player in clinical research is seeking a Clinical Research Associate (CRA) to join their dynamic team. In this role, you will perform vital monitoring and site management tasks to ensure compliance with protocols and regulations. Your expertise will help develop recruitment plans and maintain communication with sites, ensuring quality and compliance. This is a fantastic opportunity to contribute to impactful studies while working with a collaborative team. If you're passionate about advancing healthcare through research, this position is perfect for you.

Qualifications

• Minimum of 1 year of on-site monitoring experience, including oncology.
• Knowledge of GCP and ICH guidelines is essential.

Responsibilities

• Conduct site monitoring visits in compliance with GCP and ICH guidelines.
• Track study progress including regulatory submissions and recruitment.

Skills

On-site monitoring experience

Knowledge of GCP and ICH guidelines

Communication skills

Organizational skills

Problem-solving skills

Proficiency in Microsoft Office

Education

Bachelor's Degree in a scientific or healthcare field

Tools

Microsoft Office

Job description

IQVIA Biotech is hiring for CRA 2

Requirements:

• Minimum of 1 year of on-site monitoring experience, including oncology.

Job Overview

Perform monitoring and site management work to ensure sites conduct studies and report data as per protocol, regulations, and sponsor requirements.

Essential Functions

1. Conduct site monitoring visits (selection, initiation, monitoring, close-out) in compliance with GCP and ICH guidelines.
2. Collaborate with sites to develop and track subject recruitment plans.
3. Provide protocol and study training to sites; maintain communication to manage expectations and issues.
4. Assess site practices for quality and compliance; escalate issues as needed.
5. Track study progress including regulatory submissions, recruitment, CRF completion, and data queries.
6. Ensure site documents are properly filed and maintained per GCP and regulatory standards.
7. Document site management activities, submit visit reports, follow-up letters, and other documentation.
8. Coordinate with study team members for project support.
9. If applicable, support development of recruitment plans and manage site finances.

Qualifications

• Bachelor's Degree in a scientific or healthcare field preferred; equivalent experience may be accepted.
• At least 1.5 years of on-site monitoring experience.
• Knowledge of GCP and ICH guidelines.
• Good therapeutic and protocol knowledge.
• Proficiency in Microsoft Office and familiarity with mobile devices.
• Strong communication, organizational, and problem-solving skills.
• Ability to work effectively with teams and clients.

IQVIA is a leading provider of clinical research and healthcare insights. Learn more at https://jobs.iqvia.com.

We are an equal opportunity employer. More info at https://jobs.iqvia.com/eoe.

The salary range is $69,800 - $226,800 annually, with potential additional incentives and benefits.