Country Submission Specialist II, Israel
Here at inVentiv Health Clinical we are currently recruiting for a Country Submission Specialist II to be based in Israel.
inVentiv Health: Work Here. Matters Everywhere.
A local specialist regarding regulatory Institutional Review Board (IRB) and Ethics Committee (ED) processes and documentation requirements for the start-up and conduct of clinical trials according to Good Clinical Practice and local regulations. A Study Start Up Specialist may be assigned to more than one project.
* Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation, and provide updates of local processes and requirements to the Regulatory Intelligence portal
* Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions
* Compile and submit CTAs to Regulatory Authorities and IRB/EC (if applicable)
* Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process
* Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents
* Complete review of essential documents following Essential Document Checklist QC
* Arrange and review translations of relevant study documents
* Provide regular local status updates to project lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems as required for assigned projects
* Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements
* Support other departments as necessary
* Identify site issues during start-up process, resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues
* Train and mentor other associates on local regulations and internal procedures
* Complete assigned training programs and apply learning
* Complete necessary administrative tasks
* May perform other duties as assigned
The ideal candidate will need the following experience / skills to be considered:
* Bachelor's Degree in life science, pharmacy, nursing or RN, or equivalent clinical research experience
* Relevant experience in preparing EC and regulatory submissions
* Good understanding of principles, concepts, practices and standards of clinical research.
* Ability to learn and follow task specific procedures, be attentive to detail and place importance on accuracy of information
* Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
* Occasional travel may be required
* Competitive remuneration package with excellent benefits
* Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
* Opportunity to work within a successful and rewarding environment.
To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com
inVentiv Health Clinical delivers high quality drug development programs and clinical staffing solutions of all sizes around the world to achieve our vison - Shortening the distance from lab to lifeTM