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

IQVIA; South Bend (IN); On-site; USD 69,000 - 227,000; Full time

Job summary

An established industry player in clinical research is seeking a CRA 2 to ensure compliance in study conduct and data reporting. This role involves conducting site monitoring visits, collaborating with sites on recruitment plans, and maintaining communication to manage expectations. The ideal candidate will have a strong background in monitoring, knowledge of GCP and ICH guidelines, and excellent organizational and communication skills. Join a dynamic team dedicated to advancing healthcare through innovative research and make a meaningful impact in the field.

Qualifications

• At least 1.5 years of on-site monitoring experience required.
• Knowledge of GCP and ICH guidelines is essential.

Responsibilities

• Conduct site monitoring visits according to regulatory standards.
• Collaborate with sites to develop and track subject recruitment plans.

Skills

On-site monitoring experience

Knowledge of GCP and ICH guidelines

Strong communication skills

Organizational skills

Problem-solving skills

Proficiency in Microsoft Office

Education

Bachelor's Degree in a scientific or healthcare discipline

Tools

Microsoft Office

Job description

IQVIA Biotech is hiring for a CRA 2 position

Minimum requirements: At least 1 year of on-site monitoring experience, including monitoring in oncology.

Job Overview

Perform monitoring and site management to ensure study conduct and data reporting in compliance with protocols, regulations, guidelines, and sponsor requirements.

Essential Functions

1. Conduct site monitoring visits (selection, initiation, monitoring, close-out) according to scope of work and regulatory standards, including GCP and ICH guidelines.
2. Collaborate with sites to develop and track subject recruitment plans to meet project needs.
3. Provide protocol and study training to sites and maintain communication to manage expectations and issues.
4. Assess site practices for quality and compliance, escalating issues as needed.
5. Track study progress, including regulatory submissions, recruitment, CRF completion, and data queries; support start-up if applicable.
6. Maintain documentation in the Trial Master File and ensure Investigator's Site File compliance with GCP and regulations.
7. Prepare and 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 per agreements.

Qualifications

• Bachelor's Degree in a scientific or healthcare discipline preferred.
• Minimum of 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 build effective working relationships.

IQVIA is a global leader in clinical research services and healthcare intelligence. Learn more at https://jobs.iqvia.com.

IQVIA is an equal opportunity employer. More info at https://jobs.iqvia.com/eoe.

The salary range is $69,800 - $226,800 annually, with actual compensation based on qualifications, location, and schedule. Additional incentives and benefits may apply.