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.
Location: US (Remote)

QUALIFICATIONS:

• Bachelor’s degree in a life science field
• At least 2-3 years relevant industry experience in clinical research environment
• Familiarity with medical terminology
• Formal GCP Certification required, CRA Certification preferred
• Basic computer skills with proficiency in Microsoft Word and Excel required, PowerPoint and Database experience desirable
• Ability to foster relationships with clinical sites and colleagues
• Ability to support several projects simultaneously, a flexible working style and attention to detail are essential
• Able to work independently with excellent time management skills
• Approximately 50% travel that will vary over time, including limited international travel (able to travel abroad and obtain relevant visas)

• Conduct site qualification, initiation, monitoring and closeout visits 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 of 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
• 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
• Follow through after visit to outstanding requests/needs are fulfilled.
• Ensure compliance with protocol and overall clinical objectives
• Raise issues of significance to the appropriate level for resolution
• Ensure investigator involvement in the study and IRB/EC oversight
• Responsible for accurate and timely oversight and maintenance of TMF
  Requirements: