Senior Clinical Research Associate (CRA) - Phase II/III Oncology (High-Risk Neuroblastoma)
Contract: 12-month
Department: Clinical Operations
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.