Ex-Vivo Clinical Specialist II (Jacksonville, Florida) (Relocation assistance available)

Ex-Vivo Clinical Specialist II

Lung Bioengineering, a subsidiary of United Therapeutics, is seeking a skilled and mission-driven Ex-Vivo Clinical Specialist II to help transform the future of lung transplantation. In this critical role, you'll learn to perform ex-vivo lung perfusion (EVLP) procedures to evaluate and optimize donor lungs for transplantdirectly impacting patient lives. You'll work hands-on with advanced clinical technology, collaborate with transplant centers and organ procurement organizations, and help ensure seamless logistics and regulatory compliance. This is more than a jobit's a unique opportunity to be part of a fast-paced, purpose-driven team on the forefront of life-saving innovation. If you're a seasoned transplant or critical care professional with strong surgical skills, sterile technique, and a drive to make a difference, we'd love to hear from you.

The Ex-Vivo Clinical Specialist II will develop the skills necessary to perform the clinical ex-vivo lung (EVLP) procedure. This role will evaluate donor lung suitability, manage organ logistics, perform the EVLP procedure, and coordinate with organ procurement organizations and transplant center teams.

Perform EVLP Execution Responsibilities, to include:

• Coordinate clinical team arrival to LBE EVLP facility for surgical suite set-up;
• Prepare and set up EVLP systems and equipment according to established protocols;
• Create and control an aseptic zone;
• Evaluate physical lung condition and lead surgical cannulation/reconstruction of vessels and trachea;
• Operate and maintain the EVLP system and associated equipment;
• Manage all aspects of the EVLP procedure, including lung assessment, venous gas sampling, bronchoscopy, x-ray collection, recruitment, and deflation;
• Collect and conduct laboratory tests and analysis on preserved lungs to evaluate suitability for transplant;
• Maintain communication with LBE Medical Consultants and accepting transplant surgeon;
• Address and resolve medical/safety/eligibility questions from accepting transplant centers;
• Monitor adherence to protocols and determine EVLP case completion in conjunction with LBE Medical Consultant and accepting surgeon;
• Follow OPTN lung packaging procedures and prepare surgical area for next EVLP procedure;
• Assist the transplant center with post-EVLP logistics;
• Adhere to all safety protocols and procedures, including proper handling and disposal of hazardous materials and surgical waste;
• Maintain all regulatory compliance frameworks associated with clinical procedures including, but not limited to FDA, UNOS, OPTN, CLIA, and CMS at the US federal and state level, as well as that of Health Canada

Perform General Duties, to include:

• Participate in clinical review meetings and other administrative and scientific activities;
• Participate in quality control and quality assurance activities, including deviation documentation and SOP review;
• Collaborate and perform experiments with pre-clinical and translational medicinal colleagues in assessing the potential of new lung therapeutic development as needed;
• Attend staff meetings and provide input, as needed, into operational, clinical and regulatory development plans;
• Adhere to on-call schedule as well as support regular daytime office hours;
• Work within all applicable Lung Bioengineering policies and procedures

Perform Referral Management Responsibilities, to include:

• Work with contracted call center to triage incoming EVLP referrals;
• Evaluate donor lung suitability from Organ Procurement Organization (OPO) or transplant center EVLP referrals;
• Review donor medical chart to confirm device inclusion and exclusion criteria;
• Initiate referral documentation in LBE's data collection platform;
• At the request of the OPO, assist in identifying EVLP transplant centers;
• Assist OPO or transplant center with pre-EVLP logistics to ensure organs arrive within time frame required to execute EVLP procedure

Perform all other duties as require

Minimum Requirements:

• Associate Degree in a related field, or commensurate experience and/or combination of education and experience
• 4+ years of experience as a Procurement Transplant Coordinator with critical care experience managing donor patients with an Associate's Degree or 2+ years of experience as a Procurement Transplant Coordinator with critical care experience managing donor patients with a Bachelor's Degree
• 2+ years of experience in two of the following three areas: sterile technique, direct participating in surgical procedures, or critical care including ventilator management and blood gas interpretation
• Upon hire, ability to train onsite in Jacksonville, FL; Silver Spring, Maryland
• Upon initial training completion, successfully passing any qualification requirements
• Demonstrated specialized knowledge of lung physiology and mechanics
• Skilled with data collection and analysis
• Ability to operate Apple and PC; Microsoft Office Suite skills: Word, Excel, Outlook, PowerPoint required, as well as Adobe Acrobat, etc.
• Must be able to follow procedures and be competent in sterile technique and basic surgical skills, including suturing and tying

Preferred Qualifications:

• Bachelor's Degree in a related field, or commensurate experience and/or combination of education and experience
• 2+ years of experience in advanced practice organ procurement/transplant CPTC - Certified Procurement Transplant Coordinator

Job Location:

This role is based 100% onsite at our facility in Jacksonville, FL, Lung Bioengineering requires this candidate to live within an hour driving distance from the Jacksonville office. Relocation assistance is available as needed.