Clinical Research Assistant

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry's broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

• Build What Matters – Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale – Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People‑Centered Culture – Thrive in a culture that values accountability, inclusion, and continuous development.

The Clinical Research Associate will be responsible for conducting day‑to‑day work associated with analytical and clinical studies conducted by Luminex, A Dia Sorin Company for inclusion in regulatory submissions for in‑vitro diagnostic devices. Planning and execution of in‑house clinical studies as well as training and monitoring of external clinical sites.

• Day‑to‑day “hands on” work associated with in‑house clinical studies.
• Identify, qualify, initiate, monitor, and close out investigational sites; prepare accurate and timely visit reports from all site visits; review and finalize visit reports.
• Ensure studies are carried out according to the study protocol, SOPs, ICH/GCP regulations, and study‑specific manuals and procedures.
• Develop and maintain good working relationships with Principal Investigators and Study Staff.
• Track and report on progress of studies including site activation, subject enrollment, and monitoring visits.
• Create clinical study document designs and tracking tools.
• Investigate queries, monitor discrepancies, and manage investigational device accountability and reconciliation processes.
• Monitor printed Case Report Forms (CRFs) and Electronic Data Capture (EDC).
• Collection and analysis of experimental data generated in‑house and externally.
• Qualification and monitoring of external clinical sites in accordance with study protocols and applicable regulations and standards (e.g., 21 CFR Part 812, GLP, CLSI, ICH).
• Design of experiments (with assistance of more experienced colleagues).
• Develop study tools and forms (e.g., Enrollment logs, Data Record Forms, Case Report Forms, etc.).
• Contribute to the writing of study protocols and reports.
• Assist with site contracts and budget preparation.
• Train and provide technical support (troubleshooting) to external sites.
• Coordinate and track clinical supplies shipped and used at clinical sites.
• Acquisition of clinical specimens for inclusion in research or clinical studies.
• Maintenance of study documentation and data history files.
• Contribute to the writing of SOPs, DMRs, BPRs.
• Interact with other LMD departments and external service providers, if required (e.g., Sequencing facilities, CROs).
• Additional product development & clinical tasks, as needed.
• Other duties as assigned.

• Minimum
  
  B.Sc. in chemistry, biology, molecular biology, or a related subject; post‑graduate diploma or 1 year work experience preferred but not required, OR college degree (technical subject) plus at least 2 years work experience, OR college degree (technical subject) plus at least 3 years work experience.
• Previous work experience with analytical or method validation studies, preferably in GLP/GMP laboratory with an understanding of documentation requirements.
• Preferred: any additional education or experience beyond the minimum.

Receive a competitive salary…