Unblinded Clinical Research Associate / Специалист по мониторингу клинических исследований - вакансия 13638738

Обновление вакансии
03.02.2021 в 15:24


Профессия: Медицина, фармацевтика

Регион: Новосибирская область

Город, район: Новосибирск

Текст вакансии:

We are currently looking for talented Clinical Research Associates to join our team in Siberia. You will be working within our Flexible Solutions department dedicated to one sponsor/client. Would you like to work for one of the best known big pharma companies? Our sponsor is a global pharma company with high working standards. Are you passionate about growing in Clinical Field? We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials. Do you like responsibilities and challenges? As a Clinical Research Associate you will lead all aspects of study site monitoring according to Covance SOP, ICH guidelines and GCP. You will take part in 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. We offer a home based position so you will not spend time on unnecessary travels but at the same time we highlight a true live relationship between colleagues. 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. Our sponsor invests heavily in training and crafts modern system of Clinical Trials so if you are passionate about working with a phenomenal team and expand your horizons feel free to reach us. Responsibilities include:
All details 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 cooperation 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
Readiness for on-site work: travel might take up to 70% of your working time (working with patients and investigators in the hospitals)
Previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) 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 Good working level of English
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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