Clinical Research Associate

Описание

Accell Clinical Research is looking for a determined and motivated Clinical Research Associate (CRA). CRA is responsible for monitoring the performance of all study sites from A to Z and providing a link between a project team and investigators. CRA’s primary focus is expected to be on meticulous site management via executing all types of site visits, monitoring sites’ deliverables, IMP, and all related items supply. Other responsibilities include, but are not limited, to: identification of investigators and site selection; conducting pre-study visits for the qualification of investigators and sites; compiling regulatory packages; conducting all types of initiation, monitoring, close-out, and audit visit attendance; completing monitoring trip reports, reports study progress, escalating issues related to the protocol according to ACCELL and/or Sponsor timelines and quality; conducting on-site investigational product and study supply accountability and management; facilitating communication between an Investigator and the Sponsor; preparing and negotiating study budgets for the site, investigator, and study vendors; preparing, organizing, and overseeing the site, investigator, and vendor payments; managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution. We are looking for a professional with: a solid knowledge of written and spoken English (upper-intermediate level or higher), a university degree in the health-related field (Medical Doctor degree would be a plus), strong work ethics and sound management skills, and at least 1 year of clinical research work experience. The person applying should be willing to actively participate in the corporate life of the company (including training sessions and other activities) and to travel a lot (approximately 50% of the total working time).