Your responsibilities will include:
Clinical Role -
- Assist in the site qualification, and initiation processes for TAVR trials in the US. Support Clinical department, Clinical Research Associates (CRA – Monitors and technical support) in ensuring and documenting clinical site and investigator readiness for participation in an investigation trial.
- Key contact with the physicians and the research team during the patient screening and enrollment for TAVR clinical investigation, providing the support needed to collect all required screening materials for review by the assigned review committee and/or the sponsor.
- Assist the Clinical department and the hospital research team during the conduct of the study, as well as after the TAVR procedure, in all study-required data collection, including but not limited to adverse and serious adverse events reporting, source data collection, CT and echocardiographic images, etc.
- Device Management: Monitor inventory levels, initiate logistics, i.e. shipments and movement tracking of investigational products according to regulatory and company guidelines. Monitor the levels and expiration dates of investigational product in the field. Coordinate communication between internal and external customers to facilitate return of product according to departmental SOP.
- Ensure clinical trials are compliant to regulatory and company guidelines.
- Supports company goals and objectives, policies and procedures, Good Clinical Practices and regulatory agencies regulations.
Education/Training Role -
- May assist in the development of the TAVR training plans/materials. This includes but is not limited to: hands-on training such as simulated procedures and SIM models, as well as training materials development and preparation. Presentation of didactic sessions, study cases and other training-related presentations at investigator and research coordinator meetings, and other training events.
- Educate and train physicians, hospital personnel and hospital staff on technical matters relating to the company products by conducting and/or coordinating one-on-one training sessions, in-service education programs, and seminars and/or outside symposiums. Provide training and resources for hospital staff to enable them to conduct training for their personnel ("train the trainer").
Technical/Engineering Role -
- Assist in the clinical study procedure (sterile field), playing a key role in device preparation, as well as providing technical support and device and system troubleshooting as needed. Key role in maintaining compliance for peri-procedural data capture (images, steps of device delivery and performance, operators’ feedback, etc.) during the study procedure, enabling close monitoring of the device performance and procedural enhancement through constant communication with the field engineers.
- Responsible of the development of the internal case summary reports template as well as their completion.
- Work closely with the in-house engineers, participating in regular on-site training on the design implementation of the device, as well as any changes related to the design. Communicate design changes to the field as appropriate.
What we’re looking for in you:
- Bachelor Degree and higher in Engineering, Sciences, Nursing or equivalent
- 8 + years Clinical Research experience including coordinating multi-center trials and/or significant experience in the structural heart field with established technical expertise and knowledge
- Experience in presenting, writing and teaching clinical and medical information
- Experience with group presentations and hands-on experience with interventional/surgical cardiac procedures
- Ability to travel approximately 75%
- Excellent written and verbal communication skills, very strong interpersonal skills including proficiency in medical terminology
- Clinical Research experience in Medical Device
- Experience coordinating multi-center Cardiology trials
- Knowledge of Good Clinical Practices and ICH Guidelines and compliance for clinical trials
- Personal computer skills, including proficiency in word processing, spreadsheet and computer database skills