Clinical Operations Coordinator

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 (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 responsibilities related to CTMS.

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, and maintenance of equipment.
• Other duties as assigned.

Requirements

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

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 meet 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.

Working Conditions

• Biological or chemical hazard exposure: Frequently
• Standing and lifting: Frequently
• Dealing with people: Constantly
• Working alone: Occasionally
• Vision (color): Occasionally

Travel Requirements

• 95% onsite at Luminex office
• 10% domestic travel may be required
• 5% international travel

Benefits

Diasorin offers a competitive rewards package focused on your overall well-being. We provide 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, where awards depend on individual and organizational performance.