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

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

Job summary

An established industry player is seeking a Clinical Research Associate to join their dynamic team. In this pivotal role, you will perform site monitoring and management, ensuring compliance with regulatory standards and study protocols. Your expertise in GCP and ICH guidelines will be crucial as you collaborate with sites to optimize recruitment and manage project expectations. This role offers a competitive salary range and the opportunity to contribute to impactful clinical research initiatives. If you're passionate about advancing healthcare through research, this position is an exciting opportunity to make a difference.

Qualifications

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

Responsibilities

• Perform site monitoring visits and ensure compliance with protocols.
• Manage progress of studies and track regulatory submissions.

Skills

On-site monitoring experience

Knowledge of GCP and ICH guidelines

Strong communication skills

Organizational skills

Problem-solving skills

Time management skills

Financial management skills

Education

Bachelor's Degree in a scientific discipline or healthcare

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

iPhone

iPad

Job description

IQVIA Biotech is now hiring for CRA 2

Requirements:

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

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

1. Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., GCP and ICH guidelines.
2. Work with sites to adapt, drive, and track subject recruitment plans to meet project needs.
3. Administer protocol and related study training to assigned sites and establish communication to manage project expectations and issues.
4. Evaluate the quality and integrity of site practices, escalate quality issues as appropriate.
5. Manage progress of studies by tracking regulatory submissions, recruitment, CRF completion, and data queries. Support start-up phase if applicable.
6. Ensure site documents are available for filing in the TMF and verify ISF maintenance according to GCP and local requirements.
7. Create and maintain documentation regarding site management, visit findings, and action plans.
8. Collaborate with study team members for project support.
9. Support development of site-specific recruitment plans and site financial management if applicable.

Qualifications

• Bachelor's Degree in a scientific discipline or healthcare preferred; equivalent education, training, and 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 Word, Excel, PowerPoint, and familiarity with laptop, iPhone, and iPad.
• Strong communication, organizational, and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish effective working relationships.

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

IQVIA is an equal opportunity employer. Consideration for employment will be given without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected status. More information at https://jobs.iqvia.com/eoe

The potential base pay range for this role is $69,800 - $226,800 annually, with actual offers based on qualifications, location, and schedule. Additional incentives, bonuses, and benefits may be provided.