• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned• Responsible for all aspects of site management as prescribed in the project plans• General On-Site Monitoring Responsibilities• Ensure the study staff who will conduct the protocol have received the propermaterials and instructions to safely enter patients into the study• Ensure the protection of study patients by verifying that informed consentprocedures and protocol requirements are adhered to according to the applicableregulatory requirements• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or otherdata collection tools by careful source document review. Monitor data for missingor implausible data• Ensure the resources of the Sponsor and Covance are spent wisely byperforming the required monitoring tasks in an efficient manner, according toSOPs and established guidelines, including managing travel expenses in aneconomical fashion according to Covance travel policy• Prepare accurate and timely trip reports• Responsible for all aspects of registry management as prescribed in the project plans• Undertake feasibility work when requested• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor

Dossier packing for new applications and maintenance or updates submissions for registered products to the MCC; patient information leaflet and package insert compiling for new submissions and maintenance for different African countries regulatory authorities including Botswana, Namibia, Malawi and South Africa.

Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems, assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation. Assist with periodic review of study files for accuracy and completeness. Act as a central contact for the clinical team for designated project .Perform administrative tasks to support team members with clinical trial execution. Preparation, handling, distribution, filing, and archiving of clinical documents.Assitst pre-tria l documents collection, Site selection and initiation preparations, site study supply management and tracking, submitting and notifying the MCC and Ethics Committee of the pre-trial, in-trial and post-trial study related regulatory documents.

Assisting, mentoring and monitoring second and third year Biotechnology students with their practical course that is composed of biochemical tests for identifying unknown bacteria, RNA isolation and RT-PCR, mini-preparation of plasmid DNA, restriction digestion, electrophoresis, transformation, protein extraction and purification, and SDS PAGE

Assisting the Diabeties and Research Group with cell and molecular bilogy reseaech in the lab these include: mini-preparation of plasmid DNA, restriction digestion, electrophoresis, transformation, protein extraction and purification, and SDS PAGE.