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.
Main Responsibilities :
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.
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.
In return we will offer :
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.
Location : Russia, office based in Moscow or St.-Petersburg.