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
- 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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