Friday, April 6, 2012

Vacancies : Clinical Research Associate (Covance)

Job Title             Clinical Research Associate II
Company Name : Covance
Job Code            : 32867BR 
Locations           : India
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)
Experience        : Minimum of four(4) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
 
Skills and knowledge:

  • 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
  • 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 and interpersonal skills
  • Good analytical and negotiation skills
  • Computer competency
  • Fluent in local office language and in English, both written and verbal
  • Works efficiently and effectively in a matrix environment
Job Profile : 
  • 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
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