Senior CRA – Denmark

Location:

Frederiksborg, Zealand, Denmark

Salary:

Negotiable

Type:

Contract

Start Date:

As Soon As Possible

Contract Period:

To be confirmed.

Main Industry:

Search Health, Nursing & Social Services Jobs

Advertiser:

SEC Recruitment Ltd

Job ID:

132476629

Posted On:

25 November 2025

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.
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Ensure compliance with the Phase II/III neuroblastoma chemotherapy protocol.
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Perform source data verification and ensure eCRF accuracy.
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Oversee timely AE/SAE reporting and safety documentation.
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Confirm appropriate paediatric informed consent and assent processes.

Regulatory & Quality Oversight

Maintain essential documents and support audit/inspection readiness.
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Verify chemotherapy handling, storage, and accountability.
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Assist with managing protocol deviations and implementing CAPAs.

Data & Communication

Conduct risk-based monitoring and manage data queries.
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Prepare high-quality monitoring visit reports.
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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.
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2+ years of CRA monitoring experience in interventional clinical trials.
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Experience in oncology, ideally paediatric or complex solid tumours.
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Understanding of chemotherapy safety considerations.
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Ability to travel regularly.

Preferred

Experience in paediatric oncology or rare paediatric diseases.
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Familiarity with neuroblastoma studies, risk-based monitoring, and eTMF systems.

Key Competencies

Strong attention to detail and analytical capability.
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Commitment to patient safety, particularly in paediatric populations.
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Excellent communication and relationship-building skills with site staff.
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Ability to manage multiple priorities independently and proactively.

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