Clinical Research Associate

Company Description

Innoventric is a Structural Heart medical device company specializing in developing percutaneous heterotopic cross-caval solutions for Tricuspid Regurgitation.

Role Description

This is a full-time on-site role for a Clinical Research Associate position, as part of a team, reporting to the head of clinical operations. The Clinical Research Associate will be responsible for:

• Transform pre-clinical and V&V data into clinical trial submissions, including constructing and writing required documents (e.g., IB, IFU, ICF, Clinical Protocol, etc.).
• Recruit clinical sites/PIs into the study, and perform all site-opening activities (e.g. – site qualification, EC submission, Clinical trial budget and agreement, site initiation visit, etc...).
• Perform patient screening/eligibility assessment and manage study progress/patient enrollment rate.
• Manage clinical procedures on site, including instructing the study teams and operators (interventional cardiologists) in performing the implantation procedure.
• Manage CRF and patient FU and monitor the clinical site data documentation.
• Manage the periodic and AE reporting to competent authorities.
• Acquire and analyze overall clinical trial data.
• Assemble and communicate with the various study officers/committees (CEC, DSMB, etc…).
• Take part in the Clinical Study Report (CSR) writing.

Qualifications

• Science/life-science academic degree - must
• 3+ years of experience in medical device clinical trials (from a medical device company in the cardiology field – an advantage)
• 3+ years of experience with US/EU-based clinical trials
• Extensive knowledge of ICH-GCP (GCP/CRA accreditations – an advantage)
• Extensive knowledge of EU/US/IL clinical trial regulations
• Attention to detail and ability to work in a fast-paced environment
• Excellent verbal and written English
• Influential and assertive communication skills, ability to motivate
• Good technical and scientific understanding
• Availability and willingness to travel abroad (up to 25%) – must