The technology is based on an innovative new form factor for the use of Magnetic Resonance (MRI) that enables accurate and rapid surface imaging for real-time assessment of tissue microstructure in the operating room.
The position requires attendance at the operation room, operating CC's technology, and documenting study-related CRF's. The right person will get familiar with the supported product, and the customer needs and provide excellent clinical Support and Customer Service. The CRA/CAS will report to the Director of Clinical affairs.
Roles & Responsibilities:
· Building and maintaining mutually beneficial relationships with physicians, site staff, key administration, other personnel, and necessary.
· Communicate with sites and provide support and guidance regarding the clinical study's technical, operational, and logistical aspects.
· Documentation of study CRFs and Post-marketing feedback per regulatory requirements and company SOPs.
· Provide support to the clinical department and serve as the company's representative on site.
Skills and Experience
· A minimum of a Bachelor's degree (preferably Bioengineering, Life science, or similar) or four years of relevant professional work experience
· 1-2 years of professional technical/clinical training experience in a similar position in medical devices (Hands-on) and clinical knowledge of the healthcare industry, clinical trials, GCP, disease states, and therapeutic and institutional trends.
· Working knowledge of GCP/ICH guidelines and the clinical development process
· Experience in trials submissions to Ethics Committee/ Regulatory Board/ Competent Authorities (IEC/IRB/CA)
· An ability to be present in an OR environment and handle post-operational specimens on-site.
· Experience with clinical trial procedure SOP's and documentation.
· The ability to travel extensively and overnight locally, regionally, and internationally, sometimes on short notice.
· The position requires attending in-live patient cases and willing to work variable hours to meet patient needs.
· Fluent in English oral as written, other languages are an advantage.
· Good interpersonal and relationship skills
· Attention to detail/self-directed
· Ability to operate effectively in a fast-changing environment
· Problem solver, resourceful, motivated, team player, mission-oriented, strives for excellence