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.
About this role:
The CTM / SCRA will support the clinical department, with all aspects of studies conduct (whether regulatory, clinical, operational, or administrative, communicating intra-company and with external agents). The CTM / SCRA shall monitor study progress and communicate study activities to assess protocol adherence, among other things. The ideal candidate should have previous experience in conducting clinical trials under GCP with all aspects related to it.
The CTM / SCRA should be involved in company’s clinical trials, including setting up potential sites, initiating, monitoring, and closing the trial. Responsibilities includes, but are not limited to:
- Regulatory submissions and correspondence with Ethics Committees and Competent Authorities.
- Co-responsibility for preparation of study-related documents including regulatory processes.
- Maintain GCP Compliance within company’s clinical activities via periodical audits issues and inspections activities. Contribute to the development and review of clinical SOPs.
- Assess sub-contractors’ work quality from including co-monitoring or oversight visits with CROs (attendance and reports review), protocol deviation management, and on a regular basis communication with the study centers personnel (training of new personnel and so on).
- Electronic Case Report Forms (eCRF) administration, periodical updates, and ongoing maintenance:
- Management of study data for quality and accuracy – as per GCP requirements.
- Data Management & eCRF architect (eCRF planning, building, and ongoing maintenance).
- In charge of all database cleaning and lock.
- Preparation for independent safety committees according to medical records.
- Quarterly reporting of safety events to regulatory entities.
- Facilitation of contracts and agreements with clinical sites, vendors etc.
- Experience with General Data Protection Regulation (GDPR) in relation to study conduct in Europe.
- Periodically review of in-house study folders and electronic records for completeness and accuracy.
- Initiate request for investigator, site, and vendor payments.
- Attend study, project, and departmental meetings.
- Support development of relevant tracking tools and other internal processes to increase departmental efficiency.
- Onsite activities as per need, activities such as site initiation visit, ISF review and others.
- Support other job-related duties as assigned by the CTM, VP Clinical Affairs or designee.
- The role includes travels within Israel and abroad (~10%).
- Sc. 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).
- Experience and knowledge in clinical Data Management, eCRF development and administration.
- Knowledge and experience with applicable 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.