Senior CRA - Phase II/III Oncology
CR/156658_1764063057
Posted: 25/11/2025
- Negotiable
- Berlin
- Contract
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.
Imogen Szerdy
Consultant