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 CRA -Trip Report Reviewer (Contract)
Job Description
- Follow project issue escalation process and Covance Corrective Action Issue Resolution (CAIR) process for clinical operations issues
- Ensure site monitoring responsibility for clinical studies are conducted according to Covance Standard Operating Procedures, ICH Guidelines and GCP
- Ensure accurate and timely trip report completion and trip report review, timely filing of relevant sections of the TMF.
- Follow up on action items and protocol deviations and to be a liaison between CRA, CTL and PM for timely resolution of issues
- Liaise with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety.
- Assist with training, mentoring, and development of new employees
- Review progress of project and initiate appropriate actions to achieve target objectives
- Contribute to improvements to enhance the efficiency and quality of work on assigned projects
Candidate Profile:
- University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
- Thorough understanding of the drug development process, knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
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Experience
• In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting 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.
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
Additional Information:
Experience : 6 years
Requisition ID : 70476BR
Qualification : degree in life science
Location : India
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : Clinical Research Associate
Last date : 5th October, 2017
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