Clinical Operations Coordinator

Diasorin•Austin, TX

8d•Onsite

About The Position

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 role related to CTMS.

Requirements

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
High degree of proactivity, critical thinking, and problem-solving skills.
Excellent oral and written communication skills.
Ability to manage dynamic requests and meeting 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.

Nice To Haves

Proficient in Smartsheets, Microsoft planner, Microsoft Word, Excel, and PowerPoint programs
Ability to work independently and with minimal supervision.
Knowledge of Design Control requirements as defined by the FDA Quality System guidelines.
Proficient in hands-on laboratory work

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, maintenance of equipment.
Other duties as assigned.