Oncology CRA II — Site Monitoring & Trial Oversight

IQVIA LLC; Swillington; Sur place; GBP 30 000 - 50 000; Plein temps

Résumé du poste

IQVIA Biotech in the United Kingdom is seeking an experienced on-site Clinical Monitor to oversee oncology studies. You will conduct site visits, ensure protocol adherence, and maintain TMF/ISF documentation while coordinating with site staff and the study team.

The role requires 1 year of on-site monitoring experience, strong knowledge of GCP/ICH guidelines, and excellent English communication. A scientific or healthcare degree is preferred, with proficiency in MS Office and a willingness to

Qualifications

• Minimum of 1 year on-site monitoring experience.
• Experience monitoring Oncology studies is required.
• Knowledge of GCP and ICH guidelines.
• Proficient in English with strong communication skills.
• Bachelor's degree in scientific discipline or healthcare.

Responsabilités

• Perform site monitoring visits in line with GCP/ICH and contract scope.
• Drive and track subject recruitment plans to enhance predictability.
• Administer protocol training to sites and maintain communication.
• Evaluate study site quality and regulatory compliance; escalate issues.
• Manage progress: regulatory submissions, recruitment, CRFs, data queries; may support start-up.
• Maintain TMF/ISF documentation and site files.
• Create and maintain site management documentation including visit reports and follow-up letters.
• Collaborate with study team for project execution support.
• Support development of site recruitment plans per site; may handle site finances per agreement.

Connaissances

Site monitoring

GCP/ICH knowledge

Communication skills

English proficiency

MS Office

Formation

Bachelor's Degree in scientific discipline or health care

Outils

Microsoft Word

Microsoft Excel

PowerPoint

iPhone/iPad usage

Description du poste

IQVIA Biotech in the United Kingdom is seeking an experienced on-site Clinical Monitor to oversee oncology studies. You will conduct site visits, ensure protocol adherence, and maintain TMF/ISF documentation while coordinating with site staff and the study team.

The role requires 1 year of on-site monitoring experience, strong knowledge of GCP/ICH guidelines, and excellent English communication. A scientific or healthcare degree is preferred, with proficiency in MS Office and a willingness to