Covance

Clinical Research Associate

Job Number
2017-15684
Job Category
Clinical Research Associate
Position Type
Full-Time

Job Overview

Responsible for study startup which include IRB/IEC submission, site selection, recruitment of potential investigators, notifications to regulatory authorities, translation of study-related documentation Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned Responsible for 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 Responsible for all aspects of site management as prescribed in the project plans Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management May support in organization of meetings and other tasks as instructed by supervisor

Education/Qualifications

University/college degree (life science preferred) • In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements • Thorough knowledge of monitoring procedures • Good understanding of the clinical trial process • Able to adequately complete a trip report in English

Experience

• Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) with 1 year of phase I monitoring experience is preferred • Able to work in fast pace environment. • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines • Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs • Good planning, organization and problem solving abilities • Ability to work with minimal supervision • Good communication, interpersonal, analytical and negotiation skills • Works efficiently and effectively in a matrix environment

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