INSIGHTEC
Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy$1. .$1
Medical devices • MRgFUS • Focused ultrasound
201 - 500
Senior Clinical Research Associate
3 days ago
🏡 Remote – New York
INSIGHTEC
Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy$1. .$1
Medical devices • MRgFUS • Focused ultrasound
201 - 500
Description
• 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.
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.
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