Clinical Research Associate - #46818

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