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

IQVIA; Parsippany-Troy Hills (NJ); On-site; USD 69,000 - 227,000; Full time

Job summary

An innovative firm is seeking a Clinical Research Associate (CRA 2) to join their dynamic team. In this role, you will perform essential monitoring and site management functions, ensuring compliance with regulatory requirements and study protocols. You'll have the opportunity to enhance patient outcomes through effective study oversight and collaboration with healthcare professionals. This position offers a competitive salary range and a chance to contribute to impactful projects in the biotech industry. If you're passionate about improving health outcomes and have a strong background in clinical research, this is the perfect opportunity for you.

Qualifications

• Requires at least 1.5 years of on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines.
• Ability to establish effective working relationships.

Responsibilities

• Perform site monitoring visits and ensure compliance with GCP.
• Manage the progress of assigned studies and track regulatory submissions.
• Collaborate with study team members for project support.

Skills

On-site monitoring experience

GCP knowledge

ICH guidelines knowledge

Effective communication skills

Organizational skills

Problem-solving skills

Time management skills

Education

Bachelor's Degree in a scientific or healthcare discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Mobile devices

Job description

**IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring experience, including 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., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
2. Work with sites to adapt, drive, and track subject recruitment plans to enhance predictability.
3. Administer protocol and related study training to assigned sites and establish regular communication to manage ongoing project expectations and issues.
4. Evaluate the quality and integrity of study site practices related to protocol conduct and adherence to regulations. Escalate quality issues as appropriate.
5. Manage the progress of assigned studies by tracking regulatory submissions, approvals, recruitment, enrollment, CRF completion, data query resolution, and support start-up phases if applicable.
6. Ensure site documents are properly filed in the Trial Master File (TMF) and that the Investigator's Site File (ISF) is maintained per GCP and local regulations.
7. Create and maintain documentation regarding site management, monitoring findings, and action plans, including visit reports and follow-up letters.
8. Collaborate with study team members for project support.
9. If applicable, support development of project-specific subject recruitment plans and site financial management according to agreements.

Qualifications

1. Bachelor's Degree in a scientific or healthcare discipline preferred.
2. Requires at least 1.5 years of on-site monitoring experience.
3. Equivalent education, training, and experience may be accepted.
4. Good knowledge of GCP and ICH guidelines.
5. Strong therapeutic and protocol knowledge.
6. Proficiency in Microsoft Word, Excel, PowerPoint, and familiarity with mobile devices.
7. Effective communication skills in English.
8. Organizational, problem-solving, and time management skills.
9. Ability to establish effective working relationships.

IQVIA is committed to diversity and equal opportunity. Learn more at https://jobs.iqvia.com and https://jobs.iqvia.com/eoe.

The salary range for this role is $69,800.00 - $226,800.00 annually, with actual compensation varying based on qualifications, location, and schedule. Additional incentives and benefits may apply.

Join us in our mission to improve patient outcomes and population health worldwide. We value diverse talents with a passion for innovation and impact. Thank you for your interest in growing your career with IQVIA.