Clinical Operations Coordinator

DiaSorin•Austin, TX

66d•Onsite

About The Position

The Clinical Operations Coordinator supports the logistical execution of clinical studies demonstrating the performance and utility of in vitro diagnostic products, in accordance with applicable global regulations and standards such as 21 CFR Part 812, CLSI, and ICH. The role also supports the development and maintenance of clinical laboratory processes, equipment, and activities in line with Clinical Affairs timelines, and provides administrative support for the Clinical Trial Management System (CTMS). The position is based onsite at the Luminex office, with travel potentially required.

Requirements

Bachelor's degree in microbiology, molecular biology, biochemistry, or a similar discipline.
At least 1 year of expertise in a variety of microbiological, molecular, and biochemical laboratory procedures.
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 and ability to work well in a team-oriented environment.
Strong organization, time management, and prioritization skills.

Nice To Haves

At least 1 year of working knowledge or experience with ISO 13485:2016 standards and FDA regulations.
At least 1 year of prior medical device industry experience.
Proficiency in Smartsheets, Microsoft Planner, Microsoft Word, Excel, and PowerPoint.
Ability to work independently and with minimal supervision.
Knowledge of Design Control requirements as defined by FDA Quality System guidelines.
Proficiency in hands-on laboratory work.

Responsibilities

Coordinate across the organization and work with Clinical Affairs, Regulatory, Global Logistics, R&D, OMS, Manufacturing, and Quality Control on priorities and deliverable timelines.
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 with laboratory workflow and space design, including relocation of laboratory equipment and supplies.
Comply with company Quality Management System policies and procedures.
Perform administrative duties for CTMS and related activities.
Coordinate clinical operations projects as needed.
Track and update site inventory.
Document laboratory activities, including equipment calibration, verification, qualification, and maintenance.
Perform other duties as assigned.