Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Post : Clinical Research Associate II
Job Description
Responsibilities include:
- 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
Requirements::
- Ideally have been in all stages of clinical research monitoring experience
- Experienced in Cardiovascular or Endocrinology studies area
- 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
Candidate Profile
• 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
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Experience
Required:
• Minimum of two (2) 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
• 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
Preferred:
• One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
Additional Information:
Experience: 2 years
Location: India
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CRA
Division: Pharma
Requisition ID: 2017-14502
End Date: 25th February, 2018
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