Clinical Research Associate
CurrentClinical Research Associate covering Kenya, Sudan, Ethiopia, Uganda.• Plans conducts and provides supervisory support monitoring of the clinical trial site to ensure subject safety and compliance to GCP, protocols, and applicable regulations. • Maintain sponsor’s trial master files, ensuring their completeness and consistency with the applicable regulatory requirements• Coordinate the clinical trial activities and support the development of a monitoring plan• Conduct site training on protocol and GCP• Carry out sites assessment, feasibility, and SIV• Provide support and back up for trial monitors including co-monitoring and mentoring of junior CRAs• Identify monitoring issues and clearly communicates this to sites and effectively resolves the issues through active follow up. • Prepare the site for audits and inspection.• Provide input in the development of Clinical Trial Protocols and other trial tools development.• Prepare approval submissions packages to regulatory and IRBs and track the approval status of the trial.• Provide liaison and support for trial data management • liaise with DNDi Africa office Administrator /Finance Manager for trial-related activities and payment.• Coordinate Training, Meetings and other logistical issues related to the clinical trial• Prepare periodic reports as required to track project progress and performance.
