Clinical Research Associate II or Sr CRA, Ukraine
Here at inVentiv Health Clinical we are currently recruiting for a Clinical Research Associate II or Sr CRA to be home based in Ukraine.
As a Clinical Research Associate you will be at the forefront of the clinical trials practice. As a member of our Clinical Research Team you will reflect its unique characteristics and help world class companies to ensure the right size and custom fit for their trial needs. This is an excellent opportunity enabling you to take your careers and skills to the next level working for the world's largest healthcare clients.
* 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.
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA