Job Description:
Assures the implementation of project plans as assigned
Site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
Act in the project role of as Local Project Coordinator or Lead CRA as assigned
Education/Qualifications
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
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
Basic understanding of the clinical trial process
Experience
Minimum of four(4) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
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
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