Job Overview :
Discover new opportunities to grow your career as a Covance's Clinical Research Associate.
Covance is looking to hire SCRA - sponosor dedicated
all aspects of study site monitoring including routine monitoring and close out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits;
liaise with vendors; and other duties, as assigned
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 degree - Life Science
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 have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
Ducth and English is must
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