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About the job
Here at Labcorp Drug Development we are currently recruiting for a Centralized Trip Report Reviewer in South Africa.
Responsibilities Will Include
- Management of projects under direction of a Project Manager / Director as assigned.
- Ensure site monitoring responsibility for clinical studies are conducted according to Covance Standard Operating Procedures, ICH Guidelines and GCP. Work Closely with project teams in implementation of best TRR practices & applicable project plans as assigned (Implementation of Initiatives either independently or with team)
- Proactively identify opportunities for process improvements and work collaboratively with project team incase further action required
- Complete required trainings according to required timelines.
- Follow applicable departmental Standard Operating Procedures and Work Instructions
- Follow project issue escalation process and Covance Corrective Action Issue Resolution (CAIR) process for clinical operations issues
- Ensure follow up on issues and risks 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.
- Review progress of project and initiate appropriate actions to achieve target objectives assigned.
- Support in review of Standard Operating Procedures or Work Instructions to align with process or tool modifications
- Other duties as assigned by management: Ex: Document Review, ETMF reconciliation, other CTL tasks etc.
- University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex: Nursing certification, Medical or laboratory technology)
- 10+ years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
- Exclusive Trip Report Review experience of 2+ years us must.
Labcorp Is Proud To Be An Equal Opportunity Employer
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Vacancy Type: Full Time
Job Location: Centurion,Gauteng,SouthAfrica
Application Deadline: N/A