Clinical Operations 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.

• 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.

This position plays an integral role in the logistical coordination 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. The role also involves activities related to the development, and maintenance of Clinical laboratory processes, equipment, and activities in accordance with Clinical Affairs timeline requirements as well as administrative role related to CTMS.

• Interface across the organization and work closely with other functional groups, such as, Clinical Affairs, Regulatory, Global Logistics, R&D, OMS, Manufacturing, and Quality Control regarding priorities and timetables for deliverables.
• Coordinate domestic and international cold chain biological sample shipments.
• Purchase common laboratory materials and reagent supplies.
• Ship and receive laboratory supplies, instruments, and reagents.
• Stock and organize laboratories for optimum functionality.
• Assist in design of laboratory workflows and space design to include relocation of laboratory equipment and supplies.
• Comply with the company’s Quality Management System policies and procedures.
• Perform administrative role for CTMS and related activities.
• Coordinate clinical operations projects as needed.
• Track and update site inventory
• Document laboratory activities to include calibration, verification, qualification, maintenance of equipment.
• Other duties as assigned.

• Bachelor's Degree microbiology, molecular biology, biochemistry or similar discipline required
• 1+ Years Expertise in a variety of microbiological, molecular, and biochemical laboratory procedures required
• 1+ Years Working knowledge or experience with ISO 13485:2016 standards and FDA regulations preferred
• 1+ Years Prior medical device industry experience preferred

• [Required] High degree of proactivity, critical thinking, and problem-solving skills.
• [Required] Excellent oral and written communication skills.
• [Required] Ability to manage dynamic requests and meeting tight deadlines.
• [Required] Excellent interpersonal skills with proven ability to work well in a team-oriented environment.
• [Required] Highly organized with proven time management and prioritization skills.
• [Preferred] Proficient in Smartsheets, Microsoft planner, Microsoft Word, Excel, and PowerPoint programs
• [Preferred] Ability to work independently and with minimal supervision.
• [Preferred] Knowledge of Design Control requirements as defined by the FDA Quality System guidelines.
• [Preferred] Proficient in hands-on laboratory work

• biological or chemical hazard – Frequently
• Standing, lifting
  - Frequently
• dealing with people
  - Constantly
• working alone
  - Occasionally
• Vision (color) - Occasionally

• 95% Must work onsite at Luminex…