Clinical Operations Coordinator at diasorinsp | Austin, US | Rezi

Clinical Operations Coordinator at diasorinsp

Clinical Operations Coordinator

diasorinsp · Austin, US

3 weeks ago

Clinical Operations Coordinator

diasorinsp · Austin, US

a month ago
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About the Role

This position plays an integral role in the logistical coordination for the execution of clinical studies in accordance with applicable global regulations and standards. The role involves activities related to the development and maintenance of Clinical laboratory processes, equipment, and activities, as well as administrative duties for CTMS.

Responsibilities

  • Interface across the organization and work closely with other functional groups 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, and maintenance of equipment.
  • Other duties as assigned.

Requirements

  • Bachelor's Degree in 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.

Skills

  • High degree of proactivity, critical thinking, and problem-solving skills.
  • Excellent oral and written communication skills.
  • Ability to manage dynamic requests and meet tight deadlines.
  • Excellent interpersonal skills with proven ability to work well in a team-oriented environment.
  • Highly organized with proven time management and prioritization skills.
  • 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 (preferred).

Location

  • Onsite at Luminex office

Work Type

  • Full-time

Experience Level

  • 1+ Years

Education Level

  • Bachelor's Degree

Benefits

  • Comprehensive plan of health benefits.
  • Retirement and financial wellbeing.
  • Time off programs.
  • Wellbeing support and perks.
  • Annual incentive program (potential eligibility).

About the Company

  • 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.
  • 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.

Equal Opportunity

  • 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.