Make a Difference for Millions
BNA technology allows medical professionals as well as each and every one of us to better manage our Brain Health.
Solve Complicated Problems
elminda has spent a decade pioneering a fusion of data analytics and brain networks mapping. These quantify function and dysfunction of neurological and psychiatric disorders, outlining the overall condition of our Brain Health.
Be Part of Something Great
Our greatest assets are the people we work with. We are proud to have achieved a work environment that strives together to make something great. We operate in the most challenging arenas – Brain Health and AI. We invest in creating an enriching work environment, driven by talented people who want to share this fascinating path with us!
Senior Start up clinical research
About The Position
elminda, a leading company in the brain health technologies is looking for an experienced and passionate Senior Study Start-Up & CRA. You will join a dynamic and fast-paced environment and work with cross-functional teams to design, build and roll-out products that deliver the company’s vision and strategy.
The Senior Study Start-Up & CRA is responsible for the successful planning, management, oversight and execution of clinical trials. The span of activities is broad covering clinical activities in study start-up, initiation and will include project execution, and team training while working locally and globally. You will be involved in the daily operations of clinical programs. You must have an expert and comprehensive understanding of ICH/GCP requirements, principles, concepts, industry practices, and standards. Under the direction of the Director of Clinical & Regulatory affairs is responsible for successful execution of clinical trials according to regulatory guidelines. You must facilitate effective internal and external relationships. S/he is responsible for achievement of project goals and objectives on time and on budget.
Primary Roles & Responsibilities
- You will be involved in most Clinical activities:Conduct research and maintain proficiency of EU local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation.
- Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
- Compile and submit CTAs
- Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
- Review translations of regulatory documents.
- Provide regular local status updates to Director of Regulatory and Clinical Affairs; update appropriate study-tracking tools with local essential document and ethics committee status and maintain project tracking systems for assigned projects.
- Ensure all relevant documents are submitted to the Trial Master File (TMF)
- Support the development of start-up plans and essential document checklists.
- Perform on site monitoring when required.
- Assist in protocol writing
Essential skills & experience:
- Clinical research/monitoring experience including several years study start-up experience
- Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Strong organizational skills
- Ability to effectively interact with project team(s) and effectively communicate in English and Hebrew (additional language- German/Italian an advantage)
- Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
- Demonstrate excellent computer skills
- Excellent communication, presentation, interpersonal skills, both written and spoken.
- Occasional travel may be required UP TO 20%
- Experience in a multi center study in Europe and at least 2 years of monitoring experience.
- Experience with protocol writing.