Clinical Operations Coordinator

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.
• Care for 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.
• Aid in the 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

• 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.
• Proven ability to work well in a team-oriented environment.
• 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)

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