Clinical Study Associate I

Clinical Study Associate I

CellCarta

Wilrijk, Belgium

Summary

As a CSA I, you will be part of the Clinical Operations team, supporting the Project Manager with a range of activities related to sample review, query management, and release for testing, as well as study conduct and setup tasks. Your day will primarily involve administrative responsibilities, supporting the 3Ts: keeping projects on Task, on Track, and on Time.

Responsibilities

Study Conduct:

• Maintain study account information within a Laboratory Information Management System (LIMS – StarLIMS) and the Customer Portal;
• Prepare shipment requests through LIMS (StarLIMS);
• Support image transfer requests;
• Prepare bioanalytical reports for review by the Project Manager;
• Support study closure activities;
• Perform data entry in systems such as Medrio;
• Support signature collection, audits, document filing, and related administrative tasks.

Study Set-Up:

• Prepare applicable study documentation, ensuring smooth execution of all processes from sample accessioning through to result reporting;
• Complete study set-up within a Laboratory Information Management System (LIMS – StarLIMS), including preparation of workflows for automated test assignment and development of quality controls to ensure samples meet study-specific requirements.

Process Improvement:

• Participate in process improvement initiatives as needed.

Education

• Bachelor’s degree in life sciences, nursing, or a related field; alternatively, Business Administration or equivalent experience.

Main Requirements

• 2+ years of experience in administrative management and/or as a Clinical Research Associate (CRA) or Clinical Trial Assistant (CTA), or experience working in histotechnology laboratories preferred;
• Strong communication skills; proficient in English (written and spoken); additional languages are an asset;
• Proficient in Microsoft Office (Word, Excel, PowerPoint);
• Excellent organizational skills and ability to multitask;
• Positive, energetic attitude;
• Ability to take initiative, adapt, and thrive in a dynamic environment;
• Strong attention to detail and commitment to accuracy;
• Diligent and conscientious work ethic;
• Ability to work independently and as part of a team;
• Strong critical thinking and problem-solving skills;
• Customer- and Project Manager–focused mindset;
• Ability to communicate effectively and professionally with internal stakeholders.

It’s a bonus if you have:

• Experience in cancer research;
• Working knowledge of ICH-GCP guidelines for clinical trials;
• Experience collaborating with global or cross-functional teams.