Clinical Operations Specialist: Lab & Study Logistics

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

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