CRA II: Oncology Site Monitoring Specialist

IQVIA

Manchester

On-site

GBP 42,000 - 64,000

Full time

4 days ago

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Job summary

IQVIA Biotech is seeking a qualified Clinical Research Associate to perform on-site monitoring visits and manage site performance on oncology studies. You will ensure protocol compliance, site training, and timely regulatory submissions while maintaining strong communication with sites and the study team.

The role requires a minimum of 1 year in on-site monitoring, familiarity with GCP/ICH guidelines, and solid English communication skills.

Qualifications

Minimum of 1 year of on-site monitoring experience.
Experience monitoring Oncology studies is a must.
Bachelor's Degree in scientific discipline or health care preferred.
Good knowledge of GCP/ICH guidelines and ability to apply them in practice.
Strong written and verbal English communication skills.

Responsibilities

Perform site monitoring visits per scope of work and regulatory requirements (GCP/ICH).
Collaborate with sites to drive subject recruitment plans.
Administer protocol training to sites and maintain regular communication.
Evaluate site practices for protocol compliance and regulatory adherence.
Track regulatory submissions, recruitment, CRFs, data queries and resolutions; support start-up as needed.
Maintain site documents and TMF/ISF filing per local requirements.
Create and submit visit reports and follow-up documentation.
Collaborate with study team for project execution and issue resolution.