Oncology Clinical Research Associate — Site Monitoring Pro

IQVIA LLC; Colton; On-site; GBP 32,000 - 42,000; Full time

Job summary

IQVIA Biotech in Colton, United Kingdom, is seeking an on-site Clinical Research Associate to monitor oncology studies in line with GCP/ICH guidelines. You will conduct site visits from initiation to close-out, ensure regulatory compliance, and maintain TMF/ISF documentation.

You’ll collaborate with study teams, track recruitment, manage data queries, and support start-up activities where needed. A bachelor’s in a scientific or healthCare field and at least one year of monitoring experience are

Qualifications

• Minimum 1 year of on-site monitoring experience.
• Experience monitoring Oncology studies is a must.
• Bachelor's Degree in scientific discipline or health care preferred or equivalent.
• Basic knowledge of applicable clinical research regulatory requirements (GCP/ICH).

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with contracted scope and regulatory requirements (GCP/ICH).
• Drive and track subject recruitment plan to enhance predictability.
• Administer protocol and study training to sites and maintain regular communication to manage expectations and issues.
• Evaluate quality and integrity of site practices and escalate issues as needed.
• Monitor progress of studies: regulatory submissions, recruitment, CRF completion and data queries; may support start-up.
• Maintain TMF/ISF documentation and site files; ensure regulatory compliance.
• Document site management activities with visit reports and follow-up letters.
• Collaborate with study team members for project execution support.
• May support development of site recruitment plans per site and, if applicable, site financial management per contract.

Skills

On-site monitoring experience

Oncology studies

GCP/ICH knowledge

Communication skills

English language

Organizational skills

Team collaboration

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Laptop

iPhone

iPad

Job description

IQVIA Biotech in Colton, United Kingdom, is seeking an on-site Clinical Research Associate to monitor oncology studies in line with GCP/ICH guidelines. You will conduct site visits from initiation to close-out, ensure regulatory compliance, and maintain TMF/ISF documentation.

You’ll collaborate with study teams, track recruitment, manage data queries, and support start-up activities where needed. A bachelor’s in a scientific or healthCare field and at least one year of monitoring experience are