Winnie A. Email and Phone Number

Support program coordination and implementationDocumentation dissemination of outputsTracking of action points and key activitiesEngaging and establishing relations at national and sub national levelPolicy advocacyPartner coordinationData collectionParticipation in meetings

Community engagementsProgram coordination and implementationSupport resource mobilizationEstablishing collaborations with health facilities health workersTraining and mentorshipCoordination and support supervision of health workers

Providing Clinical expertise in conducting health facility assessment. Working closely with facility incharges of selected facilities during the assessment. Ensuring clearance for assessment been obtained from the health facilities. Data quality assessmentsSite Improvement through Monitoring Systems, Synthesise and produce daily reports and technical briefs. Mentorship of facility health workers

•Conduct technical and protocol training of investigational site personnel, as required
•Manage the content of project site-level Trial Master Files and ensure accuracy and completeness;
•Provide regular progress updates to the Project Lead
• Assisting site and data management with data query resolution
• Collaborated with CRAs, Research Assistant to resolve site issues
•Contributed to the finalization of SOPs
• Reviewed site visit reports, follow-up letters, and open action items generated by other quality assurance officers or CTM

Over seeing day to day activities in the different research hubs,
• ICH GCP E6 (R2) Guidelines and Protecting the Rights of the patients
• Maintaining regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs, and other investigator Site File (ISF) documents
• Good Documentation Practices following ALCOA-C principles
• Data Management Systems
• Adverse Events and Protocol Deviations (Identification and reporting)
• Recruitment and Retention of Research Participants
• Monitoring, Quality Assurance, and Inspections
• Clinical Trial Operations from feasibility through close-out
• Informed Consent Process

• Prepared study materials.• Screened, consented and enrolled participants.• Timely scheduled and reminded participants of their appointments.• Followed up on participants.• Applied investigational study drug on participants following HSP guidelines.• Ensured optimal sample collection and handling according to GCLP practices.• Timely data entry into the electronic data collection system.• Timely resolved data queries.