Clinical Operations Specialist — Lab & Global Logistics

DiaSorin S.p.A.; Texas; Sur place; USD 60 000 - 85 000; Plein temps

Résumé du poste

Luminex Corporation in Austin, Texas is seeking a Clinical Operations Coordinator to manage logistics for clinical studies, ensure compliance with global regulations, and support CTMS and lab workflows.

The role requires a Bachelor’s in a life science, hands-on lab experience, and collaboration across multiple departments. 95% onsite work with some travel and a strong focus on quality systems.

Qualifications

• Bachelor's Degree in microbiology, molecular biology, biochemistry or similar discipline required.
• 1+ year experience with microbiological, molecular, and biochemical laboratory procedures.
• 1+ year experience with ISO 13485:2016 standards and FDA regulations preferred.
• 1+ year prior medical device industry experience preferred.

Responsabilités

• Coordinate domestic and international cold chain biological sample shipments.
• Interface with Clinical Affairs, Regulatory, Global Logistics, R&D, OMS, Manufacturing and Quality Control for priorities and timetables.
• Perform administrative duties for CTMS and related activities.
• Document laboratory activities including calibration, verification, and maintenance of equipment.
• Track and update site inventory and support laboratory workflows.

Connaissances

Proactivity

Communication

Time management

Teamwork

Organizational skills

Formation

Bachelor's Degree in microbiology, molecular biology, biochemistry or similar

Outils

Smartsheets

Microsoft Planner

Microsoft Word

Excel

PowerPoint

Description du poste

Luminex Corporation in Austin, Texas is seeking a Clinical Operations Coordinator to manage logistics for clinical studies, ensure compliance with global regulations, and support CTMS and lab workflows.

The role requires a Bachelor’s in a life science, hands-on lab experience, and collaboration across multiple departments. 95% onsite work with some travel and a strong focus on quality systems.