Amphora Medical is a privately held bladder fulguration company developing minimally invasive products to restore the quality of life of people suffering from bladder dysfunction syndromes. They have engaged Talencio in the recruitment of this position. Located in Minneapolis, Minnesota and founded in 2011, Amphora Medical is currently working on a novel therapy that has the potential to improve bladder function and quality of life for people with Overactive Bladder Syndrome (OAB).
Amphora Medical is seeking to add a Clinical Field Specialist to support their US pivotal trial. This individual will join their team of professionals sharing common values of customer/patient focus, sense of urgency/accountability, integrity, respectful open communication and innovation.
The Clinical Field Specialist provides technical, educational, and clinical study support to assist in meeting clinical study objectives. The Clinical Field Specialist supports clinical investigators who are using Amphora Medical devices in clinical programs and will help in designing and conducting protocol and device training programs for Amphora Medical studies.
â€¢ Perform site activities in compliance with GCP and FDA regulations for clinical trials and in
partnership with the in-house clinical team.
â€¢ Interview, and screen potential clinical investigators.
â€¢ Provide technical assistance during clinical study procedures with Amphora Medical
â€¢ Support clinical trials in collaboration with other clinical team members pertaining to site
qualification, initiation and ongoing site support for clinical trials.
â€¢ Provide training for physicians, hospital personnel and research staff on study related
documents and devices in support of Amphora Medical clinical trials.
â€¢ Partner with the in-house study team and the study sites to drive study enrollments.
â€¢ Provide occasional training as well as monitoring support on an as-needed basis to study
â€¢ Document and report problems related to investigational devices.
â€¢ Submit periodic status reports.
â€¢ Bachelorâ€™s degree, preferably in Health Sciences or 4 years experience in urology setting
may substitute for Bachelor's degree.
â€¢ 5 years experience of operating room case coverage.
â€¢ Experience in medical device product training.
â€¢ Good knowledge base in anatomy and physiology.
â€¢ Ability to develop strong relationships with investigator base including study coordinators,
â€¢ Strong interpersonal skills to clearly and succinctly proctor procedures.
â€¢ Ability to interact with Amphora Medical employees to represent the investigator perspective
on product enhancements and new product development.
â€¢ Independent, self-motivated, self-starter.
â€¢ Skills in strategic thinking, problem-solving, planning and time-management.
â€¢ Ability to express ideas clearly and succinctly.
â€¢ Must be able to periodically work weekends, evenings and nights.
â€¢ Must be able to travel 70-90%.
â€¢ 1 - 2 years of medical device clinical trial experience and processes, preferred.
â€¢ Healthcare experience (e.g., RN, tech) preferred.
â€¢ Patient commitment
â€¢ Sense of urgency
â€¢ Respect and open communication
â€¢ Customer focus
Qualified candidates, please submit resumes to email@example.com