Clinical Research Associate II or Sr CRA, Israel
Here at inVentiv Health Clinical we are currently recruiting for a Clinical Research Associate II or Sr CRA to be based Israel.
inVentiv Health: Work Here. Matters Everywhere.
* Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 - 50% travel) for GCP compliance according to inVentiv Health SOPs and/or client guidelines
* Recruit investigators for participation in clinical trials
* Negotiate study budgets with investigators
* Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites
* Review draft protocols for completeness and feasibility
* Develop Case Report Forms for clinical trials
* Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators' Meetings
* Prepare and process Serious Adverse Event (SAE) reports
* Prepare project management reports for clients, project personnel, and inVentiv Health management
* Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries
* Resolve queries of CRF data with study site personnel
* Review Tables and Listings generated from study data
* Assist in writing Clinical Study Reports
* Train junior CRAs on monitoring, internal procedures, and query resolution
* When allocated by study management, submit essential/required documents to a central IRB or a country's central Ethics Committee, and, if necessary based on local requirements, the Competent Authority.
The ideal candidate will need the following experience / skills to be considered:
* Bachelor's Degree or RN
* Experience in clinical research, data management, regulatory affairs, or other relevant healthcare research position
* Experience in field monitoring of clinical trials
* Excellent written and verbal communications skills
* Ability and willingness to travel up to 50%
* Excellent organizational skills and ability to manage time and work independently.
* 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