Clinical Research Associate

The Clinical Research Associate (CRA) works under the hierarchical supervision of: Head of Clinical Operations Department.

Objective

The CRA is responsible for site monitoring ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, Good Clinical Practice (GCP), regulatory requirements, and EORTC’s expectations—with the ultimate goal of protecting patient safety and ensuring the integrity and quality of clinical trial data. The CRA serves as a key point of contact between the sponsor and investigational sites.

Main responsibilities / Major Activities

The CRA is responsible for site monitoring ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, Good Clinical Practice (GCP), regulatory requirements, and EORTC’s expectations—with the ultimate goal of protecting patient safety and ensuring the integrity and quality of clinical trial data. The CRA serves as a key point of contact between the sponsor and investigational sites.

Main Responsibilities

Build strong, professional relationships with investigators and site staff, providing guidance and support to drive high performance

Serve as a key operational representative for assigned sites within the clinical project team, in line with the study clinical operations manager

Assess site compliance with ICH\-GCP, protocol, regulatory requirements, and SOPs and implement an improvement plan with the site if needed

Oversee investigational product accountability and storage conditions

Ensure essential documents are maintained and complete in the Trial Master File and investigator site files

Identify, track, and resolve monitoring findings and protocol deviations

Ensures close collaboration between all actors of clinical trial research

Major activities

Conduct initiation, routine monitoring, “triggered” and close\-out visits according to the monitoring plan and following the EORTC Standard Operating procedures (SOPs), GCP guidelines and applicable regulations

Verify source data, including complex oncology assessments (RECIST, lab results, imaging, adverse events, dosing)

Provide training and coaching on protocol requirements, oncology procedures, safety reporting, and EDC use.

Troubleshoot operational challenges to maintain recruitment and study timelines

Collaborate with data management, safety, and medical teams to support data reconciliation

Manage site quality issues according to EORTC’s procedure

Profile

Master’s degree in life sciences (biomedical sciences, pharmaceutical sciences…)

Minimum of 2 years’ experience as a CRA, ideally within oncology studies, combined with extensive GCP expertise.

Excellent verbal and written communication skills

Excellent organization skills, ability to work independently

Proactivity and dynamism

Flexibility in respect to work assignments and new learnings

Ability to travel up to maximum 40% of working time within Europe, primarily to Belgium, France and Spain depending on language proficiency.

Languages

English (written \& spoken) is mandatory

Knowledge of any of the following languages: Spanish, French

Benefits

Permanent contract

Wage according to our Non\-Profit organisation status

Hybrid working environment (from Belgium only)

30 days holidays (full time)

Meal vouchers

Pension plan

Hospitalisation insurance and ambulatory care

Homeworking allowance

Reimbursement of public transport

Free parking

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