Clinical Study Associate (CSA)

As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We’d love to find a Clinical Study Associate to help us serve our sophisticated customers while adhering to our rigorous but sensible procedures.

As a CellCarta Clinical Study Associate (CSA) you are part of the Clinical Operations team. You perform query and planning management and support the study set-up activities. As a Clinical Study Associate you support the Project Manager on daily administrative tasks and for embodying 3T’s. Always keep the project on Task, on Track and on Time.

Based in

Wilrijk, Antwerp (Belgium)

Roles & Responsibilities

The CSA is responsible for the delivery of specific study tasks, generally overseen by the study Project Managers. The specific tasks are time sensitive and will be followed up accordingly.

The CSA ensures that the activities and tasks are accomplished within the CellCarta quality system.

Below is a non-limitative list of accountabilities.

1. Study set-up

• Preparation of applicable study documentation
• Complete the study set-up within a Laboratory Inventory Management System (StarLims)

2. Query management for short TAT (turnaround time) samples

• Preparation of new DCFs (Data Clarification Forms)
• Follow up of answered DCFs

3. Planning management

• Planning of tests after sample receipt

4. Active support of the Project Managers

5. Participate in process improvement initiatives

Purpose of the function

To support projects with internal stakeholders in order to deliver results on time in full and in agreement with the CellCarta Quality System. Clinical Study Associates have administrative skills, interest in databases and work closely with the Project Managers.

Required education

A Bachelor degree preferably in life sciences, nursing or a related field of study; Business Administration or similar expertise through experience.

Qualification and Skills

The CSA uses an arsenal of skills to successfully perform the required tasks.

On your first day, we’ll expect you to have:

• 2+ years of administrative management, and/or CRA (clinical research associate), CTA experience, or a history of working with histo-technology laboratories
• Strong communication skills, proficient in English language, both written and oral communications; other languages desirable
• Proficient in Microsoft Office (Word, Excel, PowerPoint)
• Excellent organizational skills and able to multi-task
• Positive and energetic attitude
• Able to take initiative, be adaptable, and strive in a dynamic environment
• Diligence and strong attention to detail
• Ability to work independently and as a team member
• Possesses critical thinking and problem solving skills
• Customer and Project Manager service oriented
• Communicate effectively with various internal stakeholders in a positive and professional manner

It’s great, but not required, if you have:

• Experience in cancer research
• Have a working knowledge of ICH-GCP guidelines related to clinical trials
• Worked in global locations

We offer an exciting and challenging full-time position in a multinational environment where customer focus and innovation are key business values. You will receive thorough on-the-job-training.

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