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.
Assures the implementation of project plans as assigned.
Function as leader for projects of limited scope as assigned.
Assume line management responsibilities as assigned.
Act in the project role of a Local Project Coordinator or Lead CRA as assigned.
Duties and Responsibilities: Individual Contributor
- Ensure accurate and timely trip report completion and trip report review and the quality of reports are of the highest standards, errors are minimized and that issues are escalated as appropriate
• 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 follow up on action items and protocol deviations and to be a liaison between CRA, CTL and PM for timely resolution of issues
• Responsible for the timely and appropriate communication to the clinical operations team
• 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.
• Assures the implementation of project plans as assigned
• 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