Clinical Operations Coordinator

Diasorin seeks a Clinical Operations Coordinator to support logistical coordination and execution of clinical studies demonstrating the performance and utility of in vitro diagnostic products. The role also supports clinical laboratory processes, equipment, and activities, and provides administrative support for 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, maintenance of equipment

Other duties as assigned

Preferred

1+ Years Working knowledge or experience with ISO 13485:2016 standards and FDA regulations preferred

1+ Years Prior medical device industry experience preferred

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

ISO 13485 2016

FDA Regulations

Medical Device Industry Experience

Smartsheet

Microsoft Planner

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

FDA Design Controls

FDA Quality System Requirements

Hands-On Laboratory Work

Independent Work

Benefits

Comprehensive health benefits

Retirement and financial wellbeing benefits

Time off programs

Wellbeing support

Perks

You may also be eligible to participate in an annual incentive program; any incentive award depends on individual and organizational performance.

Company

In vitro diagnostics and life science reagent kits

Saluggia, Piemonte, ITA

https://www.diasorin.com/

Founded in 1968

1001-5000 employees

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

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

1+ Years Working knowledge or experience with ISO 13485:2016 standards and FDA regulations preferred

1+ Years Prior medical device industry experience preferred

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

Required skills

Microbiological Laboratory Procedures, Molecular Laboratory Procedures, Biochemical Laboratory Procedures, ISO 13485 2016, FDA Regulations, Medical Device Industry, Smartsheet, Microsoft Planner, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Design Control

Preferred skills

1+ Years Prior medical device industry experience preferred, Ability to work independently and with minimal supervision, Proficient in hands-on laboratory work

Experience

1+ years