Covance Clinical Research Associate II/Sr CRA, Moscow in Moscow, Russia
We are currently looking for talented Clinical Research Associates to join our Clinical Operations team in Moscow.
We are proud to have an outstanding team of the best professionals on the market and are looking for people who are ready to show great performance and interest in Clinical Trials. As a Clinical Research Associate you will manage all aspects of study site monitoring according to Covance SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
You will become a part of our team who is always ready to help. You will have a possibility to devote all your professional skills and knowledge into monitoring investigational sites as we organize our work environment and responsibilities with high standards.
All aspects of site management as prescribed in the project plans
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
Education / Qualifications
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
Excellent understanding of Serious Adverse Event (SAE) reporting
Ability to resolve project-related problems and prioritize workload for self and team
You must have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
Job Number 2018-20074
Job Category Clinical Research Associate
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.