CRA II – Biotech

IQVIA

. Perform site monitoring visits, including selection, initiation, monitoring and close-out visits, in accordance with contracted scope of work and regulatory requirements.

Posted 11/11/2026full-timeReading • United KingdomJuniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in site monitoring for clinical trials, particularly in Oncology studies, while ensuring compliance with regulatory requirements such as GCP and ICH guidelines. Strong communication skills facilitate effective collaboration with study teams and site personnel.

Highest-signal resume keywords

On-Site Monitoring ExperienceOncology Studies MonitoringGood Clinical Practice (GCP)International Conference on Harmonization (ICH) GuidelinesWritten And Verbal Communication Skills

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Site MonitoringProtocol Compliance EvaluationRegulatory Submissions TrackingData Query GenerationTrial Master File ManagementStudy Documentation MaintenanceSubject Recruitment PlanningQuality Issue EscalationSite Financial ManagementCRF Completion

Soft Skills

Communication SkillsCollaboration

Industry Keywords

Clinical ResearchRegulatory RequirementsStudy TrainingInvestigator's Site FileSite Management

About the role

Key responsibilities & impact

Perform site monitoring visits, including selection, initiation, monitoring and close-out visits, in accordance with contracted scope of work and regulatory requirements.
Work with sites to adapt, drive and track subject recruitment plans.
Administer protocol and related study training to assigned sites and establish regular communication with sites.
Evaluate study site practices for protocol compliance and adherence to applicable regulations; escalate quality issues.
Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution; may support study start-up.
Ensure site documents are available for Trial Master File filing and verify Investigator's Site File maintenance.
Create and maintain site management and monitoring documentation, including visit reports, follow-up letters and required study documents.
Collaborate with study team members to support project execution.
May support development of project subject recruitment plans by site.
May support site financial management and invoice retrieval according to local requirements.

Requirements

What you’ll need

Minimum 1-2 years of experience of on-site monitoring experience.
Experience monitoring Oncology studies required.
Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
Written and verbal communication skills including good command of English language.
Full UK right to work is required; this position is not eligible for visa sponsorship.