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

IQVIA; Town of Niskayuna (NY); On-site; USD 69,000 - 227,000; Full time

Job summary

An established industry player in clinical research is seeking a dedicated CRA 2 to join their dynamic team. This role involves performing essential monitoring and site management tasks to ensure compliance with study protocols and regulatory guidelines. You will be responsible for site monitoring visits, managing study progress, and collaborating with site personnel to enhance subject recruitment. With a strong emphasis on quality and integrity, this position offers a unique opportunity to contribute to groundbreaking clinical trials. If you're looking to make a significant impact in the healthcare sector, this role is perfect for you.

Qualifications

• Minimum of 1.5 years of on-site monitoring experience required.
• Good knowledge of GCP and ICH guidelines essential.

Responsibilities

• Perform site monitoring visits and ensure compliance with study protocols.
• Evaluate quality and integrity of study site practices.

Skills

On-site monitoring experience

Communication skills

Organizational skills

Problem-solving skills

Time management

Education

Bachelor's Degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

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., 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, CRF completion, data query resolution, and support start-up phases if applicable.
6. Ensure site documents are properly filed and maintained in accordance with GCP and local regulations.
7. Create and maintain documentation regarding site management, visit findings, and action plans, including regular reports and follow-up letters.
8. Collaborate with study team members for project execution support.
9. If applicable, support development of project subject recruitment plans and site financial management per clinical trial agreements.

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.
• Good knowledge of applicable clinical research regulatory requirements (GCP, ICH guidelines).
• Good therapeutic and protocol knowledge.
• Proficiency in Microsoft Word, Excel, PowerPoint, and familiarity with laptops and mobile devices.
• Strong communication, organizational, and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish effective working relationships.

IQVIA is a leading provider of clinical research services, commercial insights, and healthcare intelligence. We are an equal opportunity employer. Learn more at https://jobs.iqvia.com and https://jobs.iqvia.com/eoe.

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