INSIGHTEC is hiring a
Senior Clinical Research Associate

Summary

Join us in our mission to make the impossible possible as a Senior Clinical Research Associate (Sr. CRA) at Insightec, a growing medical technology company transforming patient lives through innovative incisionless surgery.

Requirements

• Minimum of a 4-year Bachelor’s degree, preferably in life sciences field and good familiarity with medical terminology; experience in Neuroscience or device studies preferred
• Basic computer skills with proficiency in Microsoft suite of products, including Word, Excel, and PowerPoint, is required; Familiarity with EDC is also required
• Ability to foster relationships with clinical sites and colleagues. Experience mentoring and co-monitoring junior CRAs is preferred. Audit experience also preferred
• 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
• Excellent work ethic with desire to be a valuable contributing team member
• Approximately 50% travel that will vary over time, including international travel (able to travel abroad and obtain relevant visas) within US and Canada and as needed to the Europe, Israel and Asia; Ideal candidate will reside within USA with easy access to travel options

Responsibilities

• 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