Clinical Research Associate (CRA) - Phase II/III Oncology (High-Risk Neuroblastoma)

Contract: 12-month

Copenhagen, Denmark.

About the Role

This position supports a specialist clinical research team working across complex oncology and rare disease studies. The CRA will contribute to high-quality, patient-focused clinical trial execution in a dynamic and collaborative environment.

Role Summary

The CRA will oversee monitoring activities for a 12-month Phase II/III paediatric oncology trial evaluating chemotherapy for high-risk neuroblastoma in patients 18 months to <18 years. Responsibilities include ensuring patient safety, data integrity, and adherence to GCP, protocol requirements, and regulatory expectations.

Key Responsibilities

Monitoring & Site Management

• Conduct site initiation, routine monitoring, and close-out visits.

• Ensure compliance with the Phase II/III neuroblastoma chemotherapy protocol.

• Perform source data verification and ensure eCRF accuracy.

• Oversee timely AE/SAE reporting and safety documentation.

• Confirm appropriate paediatric informed consent and assent processes.

Regulatory & Quality Oversight

• Maintain essential documents and support audit/inspection readiness.

• Verify chemotherapy handling, storage, and accountability.

• Assist with managing protocol deviations and implementing CAPAs.

Data & Communication

• Conduct risk-based monitoring and manage data queries.

• Prepare high-quality monitoring visit reports.

• Serve as the primary contact for site staff, offering guidance and training as needed.

Qualifications

Required

• Bachelor's degree in life sciences or a related field.

• 2+ years of CRA monitoring experience in interventional clinical trials.

• Experience in oncology, ideally paediatric or complex solid tumours.

• Understanding of chemotherapy safety considerations.

• Ability to travel regularly.

Preferred

• Experience in paediatric oncology or rare paediatric diseases.

• Familiarity with neuroblastoma studies, risk-based monitoring, and eTMF systems.

Key Competencies

• Strong attention to detail and analytical capability.

• Commitment to patient safety, particularly in paediatric populations.

• Excellent communication and relationship-building skills with site staff.

• Ability to manage multiple priorities independently and proactively.