Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company's Exablate Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with medication-refractory Essential Tremor and Parkinson's Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, Florida, with additional offices in Dallas, Shanghai, and Tokyo. Follow us on Facebook, LinkedIn and Twitter or visit www.insightec.com for more information.

INSIGHTEC

Research Scientist

Oversee clinical trials for an innovative incisionless surgery company.

• 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 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.
• During study start-up and throughout study conduct, work closely with the Project Manager to review and/or draft study documents, such as Clinical Monitoring Plan, and Informed Consent Template. Lead review of site-level informed consents before and after IRB submission.
• Work with sites between monitoring visits on recruitment and enrollment challenges, 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.
• Active participation in site calls between monitoring visits.
• Support CAPA identification and resolution at research sites.
• 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.
• Organize site study files.
• Work closely with other CRAs for coverage in collecting and reviewing regulatory documentation and assuring consistency between RMF and site files.
• Generate and maintain study checklists as necessary and keep accurate records of all essential study material(s).
• Responsible for accurate and timely oversight and maintenance of RMF.
• Demonstrated expertise in understanding and managing clinical study documentation.
• Proper and timely filing of all relevant study documents and standardized filing across all studies, per applicable SOPs and regulatory standards.

Senior Clinical Research Associate

Account Manager

• The Clinical Account Manager goal is to help drive commercial utilization at new and existing Insightec neurosurgical customers. The purpose of this role is to increase the number of patients treated to reach business profitability through recurring revenue and demonstrated models of service line success
• Focus in INSIGHTEC movement disorder brain applications (neurosurgery)
• Main responsibility is to work with INSIGHTEC existing and new install-base sites to launch and grow clinical program and drive commercial success
• Achieve annual goals of number of treatments, average utilization in the region and year over year program growth in accounts to drive topline recurring revenues from the sites (service and disposables)
• Embed into customer environment and gain In-depth knowledge of their hospital operations, patient flow, financial model with focus on business and operational outcomes
• Own the administrative and clinical relationships post-capital sales and continually ensure the program performance aligns with key stakeholder priorities within customer organization
• Design and deliver on targeted referral network building (neurology) strategies that drive program volume in treatment centers within the MSA (Metropolitan statistical area)
• Be a trusted partner to customer (in clinical and business aspects) with ability to influence and have a seat at customer table for driving program success
• Interface between site and INSIGHTEC marketing, reimbursement and PR teams to facilitate program operations, navigate insurance landscape and drive patient interest

INSIGHTEC Jobs in New York City

INSIGHTEC

Senior Clinical Research Associate

INSIGHTEC

Clinical Account Manager

INSIGHTEC