Clinical Trial Associate

CardiaCare is a growing start-up company in the medical device and digital health space. We have developed the first neuromodulation wearable for treatment of Atrial Fibrillation, the world's most common cardiac arrhythmia. The company is conducting several clinical trials, in Israel and overseas. We are looking for a motivated and talented CRA to join our ongoing clinical operations. This is a great opportunity to influence and promote breakthrough clinical research, work in an innovative and creative environment, be a part of a passionate and vibrant team along side world recognized key opinion leaders and physicians from leading hospitals.

Role 

On-site, Full time Clinical Research Associate

Responsibilities

• Plan and build various tools to control and promote clinical studies patient recruitment.
• Produce and distribute content and background material for the research teams, including newsletters, brochures, posts for online promotion, etc.
• 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 activities for the future.
• Participate in training activities related to the clinical trial as well as in SIV meetings.
• 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.

Job Requirements

• 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 ICG GCP guidelines and expertise to review and evaluate medical data (GCP/ CRA accreditations – an advantage)
• 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.
• Experience in work and or oversight of EDC documentation
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint 
• Valid driver's license.
• Fluency in English and Hebrew

Advantageous

• Experience with cardiovascular related medical device clinical studies 
• Experience working in a start-up company

Personal Attributes

• Assumes high level of responsibility and accountability
• Gets the job done, egoless approach
• Excellent interpersonal skills and Collaborative approach  
• Excellent communication skills in English (written, spoken)
• Comfortable in highly dynamic environment, a multitasker at heart 
• High level of attention to details

Location- Nes-Ziona Science Park, Israel

Please send your CV to: [email protected] or upload to the platform