Clinical Research Associate (CRA)
Vectorious’ has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our first in human clinical study, we have successfully implanted our sensory device in patients across Europe and Israel, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease, keeping them stable, out of hospitals, and living longer, fuller lives.
What will you do?
- Manage all aspects of the Vectorious’ clinical trials (FIH, PILOT and PIVOTAL): perform sites’ management, monitoring (SDV), research activities’ support etc.
- Perform ongoing study activities: mange study files, manage and oversite CROs etc.
- Manage study logistics: prepare contracts, organize equipment etc.
- Support VP Clinical with FDA activities
- Manage the sub-study – Responsibility for feasibility, preparations, submissions, follow up etc.
- Support regulatory activities – Documents preparations and submissions
- Develop and review of clinical SOPs, Study Protocol, ICF and IB (clinical section)
- Maintenance of the Patient’s Database and manage all Safety related tasks, including Narrative creation and CEC-DSMB meetings
- Manage Data Management
- Regulatory submissions to Ethic Committees and Regulatory authorities in Israel and Europe
- Manage vendors including, CROs and DM throughout the clinical trial cycle
- Negotiate contractual terms and conditions with vendors, sites and consultants
- Prepare and conduct of Investigators Meeting, supporting KOLs presenting in conferences
- Establish new territories and work relationship with leading physicians
- Work closely with R&D, QA and Regulatory Affairs
What do you need to bring with you?
- Scientific degree in Life Sciences or equivalent.
- 3+ years of experience as a Clinical Research Associate or an equivalent experience (preferably in the field of Cardiology).
- Knowledge and experience with Israeli and European regulations, guidelines, and GCP.
- Excellent written and verbal communication skills in English and Hebrew, including proficiency in medical terminology from several disciplines.
- Strong multitasking ability with impeccable attention to details.
- Excellent analytical, organizational, and problem-solving skills.
- Ability to work independently and prioritize tasks.
- Experience and knowledge in clinical Data Management, eCRF development and administration – preferred.