Career Opportunities

Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.

Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values – Our Patients, Integrity, Team, Quality and Innovation.

Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.

Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.

Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.

The Clinical Research Associate (CRA) position represents an opportunity to grow within an emerging medical device company.  Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP)/ICH, and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical. The CRA has broad exposure to clinical research tasks as a combination of in-house and field work.  

Monitoring Responsibilities:

• Conduct site qualification, initiation, monitoring and closeout visits in accordance with applicable guidelines and Insightec’s SOPs and create documentation of such through accurate and detailed visit reports.
• Monitor source documents to EDC for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteria
• Review all source records for patient safety and ensure complete documentation of all subject safety events.
• Review regulatory binder to ensure complete, accurate, and up-to-date regulatory compliance at the site.
• Ensure compliance with protocol and overall clinical objectives.
• Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks.
• Ensure investigator involvement in the study and IRB/EC oversight.
• Follow-through after visits to see that all outstanding requests/needs are fulfilled.
• Raise issues of significance to the appropriate level for resolution.
• Able to help site navigate informed consent issues and support IRB submission process, as needed.

Site Management & Study Support Responsibilities

• Collaborate with Project Managers and cross-functional teams during study start-up and conduct.
• Contribute to the development and review of the Clinical Monitoring Plan, informed consent templates, and other study tools. Lead review of site-level informed consents before and after IRB submission. Work with sites between monitoring visits to ensure Essential Regulatory Documentation is current, collected and filed in Insightec TMF and site ISF.
• Work with sites between monitoring visits to ensure timely data entry and query resolution, and follow-up challenges.
• Ensure sites have submitted relevant source documents related to safety events. Work with coordinators to ensure that safety events are reported in a timely manner, and work with CPM to ensure that all information is available for DSMB reporting.
• Ensure sites are continuing follow-up of subjects in accordance with protocol requirements.
• Proactively identify and support process improvement at study or site level. Work with key stakeholders within the organization and externally to resolve.
• Participate in other activities as needed.