Clinical Operations Coordinator

Overview:

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities:

This Clinical Operations Coordinator supports the Senior Project Analyst, Clinical Operations with managing investigational devices for sponsored clinical studies. In this role, you will assist with filing, tracking, packaging and shipment of clinical device inventory. This role is critical in ensuring products are sent to sites in a timely and accurate manner, while ensuring that traceability is maintained during shipments and at individual sites.

Key Responsibilities

• Maintain and manage inventory in the clinical device warehouse and each of the storage locations
  • Organize devices by size, which study the devices are allocated for, US/OUS products, expirations, relabels, scrap
  • Ensure the warehouses maintain a temperature-controlled environment, to ensure conformity with the device storage requirements
• Follow clinical device management procedures
• Tracking and maintaining records of all investigational product (whether in Irvine or at a site) within the database system
• Ensure that devices are shipped correctly and sent in a timely manner to the clinical sites
• Develop device accountability logs for each site/shipment and ensure appropriate documentation is provided to sites for each shipment
• Manage returned devices and perform a reconciliation with the master tracker
• Support device management at off-site storage unit (organization and scrapping of stored devices)
• Maintain shipping/receiving records and filing in Clinical SharePoint folders
• Collaborate across clinical team, QA, R&D, Manufacturing, shipping/receiving
• Communicate with physicians and research coordinator at each of the study sites and answer questions in a timely manner
• Raise questions/issues in a prompt manner

Qualifications:

Required Skills

• High School or equivalent education
• 1+ years’ experience in a medical device or other regulated manufacturing industry
• Precise, rigorous, detail-oriented with strong work ethic
• Strong communication and listening skills
• Fluent in English
• Ability to read, comprehend, and follow written procedures
• Understand and follow verbal instructions
• Skilled in Microsoft platforms, such as Excel, Outlook, SharePoint, and other computer software packages
• Ability to communicate ideas, problems and solutions to supervisor and management
• Ability to work alone and in a team environment

Physical Requirements

• Clinical Operations Coordinator must work in the Irvine office
• Must be able to lift and carry up to 50 lbs.
• Requires walking, lifting, lifting above head, bending, twisting, pushing, stretching, squatting, pulling, reaching, standing, climbing, and carrying
• Position requires standing for an extended period

Pay / Compensation
The expected pre-tax pay rate for this position is $ 19.57 – $24.33 per hour. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Preferred Qualifications:

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.