Oncology CRA II - Site Monitoring & Study Oversight

IQVIA LLC; Salford; Sur place; GBP 30 000 - 52 000; Plein temps

Résumé du poste

IQVIA Biotech in the United Kingdom seeks an experienced Clinical Research Associate to perform on-site monitoring visits per GCP/ICH, with a focus on oncology studies.

You will drive recruitment planning with sites, administer protocol training, manage TMF/ISF, and collaborate with study teams to ensure data quality and regulatory compliance throughout the trial lifecycle.

Bachelor's degree in a scientific discipline or healthcare is preferred; 1 year of on-site monitoring experience is required.

Qualifications

• Minimum of 1 year of on-site monitoring experience.
• Experience monitoring Oncology studies is a must.
• Good knowledge of GCP/ICH guidelines and regulatory requirements.
• Strong written and verbal English communication skills.

Responsabilités

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per approved scope and regulatory requirements.
• Drive and track subject recruitment plans with sites to enhance predictability.
• Administer protocol and study training to sites and establish regular communication.
• Escalate quality issues and ensure investigator file maintenance per TMF requirements.
• Manage regulatory submissions, recruitment, CRF completion and data queries.
• Create and maintain site management documentation and visit reports.

Connaissances

On-site monitoring

Oncology studies experience

English proficiency

Regulatory knowledge

Communication skills

Time management

Financial management

Team collaboration

Problem solving

Formation

Bachelor's Degree in scientific discipline or health care preferred

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Laptop/iPad usage

Description du poste

IQVIA Biotech in the United Kingdom seeks an experienced Clinical Research Associate to perform on-site monitoring visits per GCP/ICH, with a focus on oncology studies.

You will drive recruitment planning with sites, administer protocol training, manage TMF/ISF, and collaborate with study teams to ensure data quality and regulatory compliance throughout the trial lifecycle.

Bachelor's degree in a scientific discipline or healthcare is preferred; 1 year of on-site monitoring experience is required.