Senior Clinical Research Associate

CardiaCare is looking for motivated and talented clinical trial personnel to join our passionate and productive team.

Title: Clinical Research Associate, reporting to Clinical Trial Manager.

This is a great opportunity to be a significant part of breakthrough clinical research and to work in an innovative and creative environment.

• Ensure the investigators and site study teams adhere to applicable regulations, ICH/GCP guidelines, local policies, and the study’s standard operating procedures. 
• Act as the main contact person for the study sites, develop strong relationships with sites to drive performance and generate new business for the future.
• Participate in training activities related to the clinical trial.
• Monitor clinical trial progress according to the monitoring plan through the performance of monitoring visits regularly. Submit written reports of monitoring activities to the sites and to the CTM.
• Ensure clinical data is accurate and complete (source data verification) and ensure data query resolution is achieved promptly. 
• Coordinate ongoing and upcoming monitoring assignments as directed by study CTM. Ensure study-related documentation (TMF/ISF) is current and complete according to regulatory requirements.
• Proactively identify and ensure timely resolution of study-related issues and escalate as appropriate to study CTM
• Coordinate logistics and administrative tasks related to the study (shipments, study supply, meetings, etc.)
• Support study tasks and projects according to known and approved timelines. 
• Prepare for and collaborate on activities associated with audits and regulatory inspections.
• Medical writing

• Science/ life-science academic degree - must
• 2+ years of monitoring experience in medical device clinical trials (cardiology field – an advantage)
• Experience with US/ EU based clinical trials -advantage
• Knowledge of ICH GCP guidelines and expertise to review and evaluate medical data (GCP/ CRA accreditations)
• Excellent record-keeping skills
• Possess excellent written and verbal communication in English
• Ability to produce accurate work to tight deadlines within a pressurized environment
• Organizational and problem-solving skills.
• Availability and willingness to travel domestically and abroad 
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint 
• Valid driver's license.
• English and Hebrew Nativ speaker