Clinical Operations Coordinator

Diasorin; Austin (TX); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Time off programs

Wellbeing support

Annual incentive program

Job summary

Diasorin is seeking a Diagnostics Specialist to coordinate clinical studies and manage laboratory operations within our Austin-area team. The role supports development and maintenance of clinical laboratory processes, equipment, and activities in line with global regulations such as 21 CFR Part 812.

CTMS administration and project coordination are key components. The successful candidate will work with Clinical Affairs, Regulatory, Global Logistics, R&D, and Manufacturing to meet timelines and

Qualifications

• Bachelor's degree in microbiology or related field is required.
• 1+ years of experience in microbiological, molecular, or biochemical laboratory procedures.
• 1+ years working knowledge of ISO 13485:2016 standards and FDA regulations preferred.
• 1+ years prior medical device industry experience preferred.

Responsibilities

• Interface across the organization and work with Clinical Affairs, Regulatory, Global Logistics, R&D, OMS, Manufacturing, and Quality Control for prioritizing 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, including relocation of equipment.
• 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 including calibration, verification, qualification, and maintenance of equipment.
• Other duties as assigned.

Skills

Proactive problem solving

Communication

Time management

Teamwork

Independent work

Education

Bachelor's degree in microbiology/molecular biology/biochemistry

Tools

Smartsheets

Microsoft Planner

Microsoft Word

Excel

PowerPoint

Job description

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 Posting

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.

Duties And Responsibilities

• 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.

Education, Experience And Qualifications

• 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

Training And Skills

• [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

Standard Working Conditions

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

Travel Requirements

• 95% Must work onsite at Luminex office
• 10% Travel may be required
• 5% International travel

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 organizational performance.

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact [e-mail].