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 : Senior Clinical Research Associate - Trip Report Reviewer
Job Posting
Responsible for timely and appropriate communication to the clinical operations team.
• Provide performance feedback of team members to respective supervisors.
• Ensure accurate and timely trip report completion and trip report review.
• Follow project issue escalation process and Covance’s Corrective Action Issue Resolution (CAIR) process for clinical operations issues.
• Ensure timely filing of relevant sections of the TMF.
• Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects
Education/Qualifications
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
• In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
• Thorough understanding of the drug development process
• Fluent in local office language and in English, both written and verbal
Candidate Profile :
• In lieu of the above requirements, candidates with > four (4) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may be considered
• Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Excellent site monitoring experience
• Excellent study site management experience
• Ability to work with minimal supervision
• Good planning and organization skills
• Good computer skills with good working knowledge of a range of computer packages
• Excellent verbal and written communication skills
• Ability to resolve project-related problems and prioritizes workload for self and team
• Ability to work within a project team
• Works efficiently and effectively in a matrix environment
• One (1) or more year’s additional experience in a related field (i.e. medical, clinical,pharmaceutical,laboratory, research, data analysis, data management or technical writing) is preferred
• Local project coordination and/or project management
Additional Information:
Experience : Min 4 years
Qualification : degree in life science
Location : India
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : Clinical Research Associate
Last date : 19th August, 2016
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