Clinical Study Coordinator

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.

Why Join Diasorin

* 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.

Job Scope

The Clinical Study Coordinator plays an integral role in supporting the conduct of analytical and clinical studies involving Luminex in vitro diagnostic devices, planning and execution of in-house clinical studies, and qualification and monitoring of external clinical sites in accordance with Clinical Affairs timeline requirements. The role also involves activities related to the logistical requirements for the execution of clinical studies in accordance with applicable global regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH) that demonstrate the performance and utility of in vitro diagnostic products.

Duties and Responsibilities

* Day-to-day "hands on" work associated with in-house clinical studies

* Coordinate execution of site contracts and site budget preparation

* Process invoices for payment and track project specific budgets and spending

* Coordinate and track clinical supplies shipped and used at clinical sites

* Collection and analysis of experimental data generated in-house and externally

* Assist with site qualification processes and support monitoring of external clinical sites in accordance with study protocols and applicable regulations and standards (eg. 21 CFR Part 812, GLP, CLSI, ICH)

* Develop study tools and forms (eg. Enrollment logs, Data Record Forms, Case Report Forms etc.)

* Collaborates with sample bank to acquire and dispense clinical specimens for use at external clinical sites

* Maintenance of study documentation and data history files

* Maintain working knowledge of current protocols and internal SOPs.

* Interact with other internal Luminex departments and external service providers, if required (eg. Sequencing facilities, CROs)

* Additional Product Development & Clinical tasks, as need arises

* Other duties as assigned

Education, Experience, and Qualifications

* Bachelor's Degree technical subject plus at least 3 years' work experience. required or

* Bachelor's Degree in chemistry, biology, molecular biology or a related subject, with additional post-graduate diploma or ≥ 1 year work experience preferred but not required; preferred or

* Master's Degree technical subject plus at least 2 years' work experience; preferred

* 1+ Years Previous work experience with clinical trials, analytical or method validation studies preferred. preferred

* Excellent communication, organizational and time management skills

* Proficiency with Microsoft Office software

What we offer

Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and…