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
