Job Summary:

The Clinical Specialist will be primarily responsible for training and supporting users of the products.  This includes teaching and training users in the correct manner to ensure that these products are used safely and effectively – both for the preservation of organs prior to transplant, and for various clinical and non-clinical research studies.  The role of the Clinical Specialist will involve national travel, primarily within North America, visiting leading sites of transplantation surgery. Team members will primarily support cases within their home region of the country (for example, Northeast, Midwest, etc.) but will also be assigned cases as required. This means that you will be required to work unsocial hours, including nights, weekends, and some very long days, which is the norm due to the unpredictable nature of organ donation and transplantation. The team is rostered to ensure that callouts are shared as much as possible. We operate a call-out policy that is renumerated.

Responsibilities:

Train and support customers in the correct operation

• • Train and support organ retrieval and transplant teams.
  • Ensure that all users understand the operation modes on the device (with and without a liver in place).
  • Maintain accurate records of all training procedures.
  • Provide a report on the status of each center with respect to the installation and training procedures.
  • Evaluate the quality of the training delivered as an ongoing and cumulative process.
  • Organize Site Initiation Visits, training sessions (in person and remote), and centralized training events.
  • Train surgeons in the preparation and cannulation of the liver prior to connection to the device.
  • Be available on an on-call basis to support transplant teams and organ procurement organizations in person using the device.
  • Create and write case study reports, and clinical case support summary forms and maintain an online database of cases.
  • Ensure that all transplant centers, procurement teams, and organ procurement organizations remain competent in the use of the device by a process of follow-up on a regular basis.
  • Ensure that existing and new team members at these sites are trained and certified, and an internal record of these training documents is maintained on the secure server.
  • Contribute towards 24-hour on-call technical support, ensuring that there is always a clinical specialist available to respond to and resolve inquiries over the telephone.
  • Work with the liver transplant teams to collect data on livers perfused and preserved on the device to build up a database of product performance and use.
  • Contribute towards a 24-hour on-call to attend cases in person as required.
  • Ensure that all calls are logged, and any outstanding issues are followed up and resolved.  
  • Collect all information and disseminate it to team members and other users as appropriate.
  • Routinely review the Instructions for Use, supporting documentation, and training videos to assist with product training.
  • Recommend and ensure changes are implemented as revised protocols are introduced.
  • Design and create new training materials, as required.
  • Produce technical bulletins as required, relating to user errors, changes to the disposable sets, device, and procedures, and ensure they are issued to all company support staff and trained users.
  • Ensure that vendor credentialing requirements are current.

Maintain Customer Relationships and Visibility in the Organ Procurement and Transplant Community:

• • Assist the VP of Clinical Operations and the Commercial team to build relationships, identify potential new users, and increase adoption of this technology.
  • Maintain customer contact details on an online database.
  • Attend local, regional, national, and international meetings and conferences, in person or virtually, on behalf of the company.
  • Assist in maintaining a database of organ donations carried out per center, the types of livers transplanted and the cases where the device has been used.
  • Collection of data information about organ donation and transplantation in general, the preferences and needs of individual units, and the status of competing technologies.
  • As the company progresses, this role will expand to cover the introduction, training, and adoption of further products.
  • Develop and maintain positive working relationships in connection with end users of all levels.

Additional Responsibilities:

• When not covering cases, you will support your manager, or other colleagues, in various assignments and tasks, either remotely from home or as assigned.
  • Ensure that all documentation meets the required standards in line with Company policy and as directed by the Quality and Regulatory department.
  • Participate in medical and scientific conferences and meetings, both inside and outside the US.
  • Participate and collaborate in research following the principles of Good Clinical Practice (GCP).
  • Maintain a current GCP certification.
  • Maintain your own professional development – for example studying medical journals to keep up to date with your knowledge of organ donation, transplantation, and the medical device field.
  • Assist the Operations team with stock and device logistics as required.
  • Assist the Service Engineers with install testing of devices and soak and acceptance testing of devices if required.
  • This list is not inclusive, and the post-holder will be expected to undertake other tasks reasonably requested by their manager.

Qualifications:

Required:

• • The legal right to work in the USA.
  • A minimum of five years of working experience -which may be within a hospital environment as a cardiothoracic perfusionist, an operating room practitioner, or in a clinical role within organ donation and/or transplantation.

Preferred:

• • A nursing qualification and/or a science-related degree.
  • Experience in clinical trials.

Skills & Experience:

The Clinical Specialist will:

• • Have broad knowledge and experience of working in operating rooms, recovery units, and intensive care units.
  • Have a good working knowledge of medical instrumentation used in these locations.
  • Be conversant in medical terminology, with an understanding of systems and processes within the human body.
  • Be up to date, and continuously remain up to date, with new techniques and developments for the promotion and maintenance of good practice.
  • Be friendly, approachable, and have excellent interpersonal skills due to the need to train and converse with clinical and technical staff at many levels.
  • Be prepared to accept a high degree of responsibility.
  • Be highly observant of people and procedures.
  • Have an analytic approach to problem-solving.
  • Have good technical, manual, and dexterity skills.
  • Be willing to work alone, as well as work collegiality as part of a team.
  • Be flexible, willing, and able to work long and unpredictable hours as and when required.
  • Self-sufficient ITC skills – literate and familiar with Microsoft Word, Excel, PowerPoint, etc.