TARSICIUS KUMIH

Title of Project: An evaluation of the cluster-randomized pilot implementation of RTS, S/AS01 through routine health systems in Ghana: A Post-Authorization Observation Study

• Successfully schedule and organize site visits whilst ensuring strong cooperation with FDA, study, and WHO monitoring teams
• Assess protocol for clarity and subject safety, review inclusion/exclusion criteria whilst classifying concerns and questions with Principal Investigator and sponsor
• Attend and participate in study-related meetings
• Advise leadership regarding specific study site-related assignments and timelines
• Track and report SAEs to IRB and sponsor whilst documenting all protocol deviations
• Explain and obtain informed consent, review medical history and demographics using LHIMS; documents in source file, and maintain with historical data, status reports, progress notes, and participants' logs to help ensure participants' safety
• Enter data from participants' logs into RedCap (pseudo-anonymization, coding, case filing, monitoring, etc.), with strict adherence to data management and protection standards
• Spearhead fieldwork and collaborate with local stakeholders and other study sites, ensuring seamless execution of activities and adherence to project timelines
• Assist with negotiating site budget and payment terms
• Maintain documents as required by FDA guidelines
• Maintain contact with IRB and prepare and submit IRB documents
• Ensure proper collection, processing, and shipment of specimens
• Complete, audit, correct CRFs, and relay CRFs to sponsor

• This project involved mapping and assessing Breast and Cervical Cancer Services in hospitals across Ghana and other African countries
• Trained on technical aspects of survey administration, data entry, submission, and safe conduct at 3+ Trainer of Trainees Workshops
• Administered survey questionnaires to 120+ medical superintendents and gynecologists across 50+ private and government health facilities in the Ashanti region of Ghana
• Compiled and submitted complete and quality data using Google Sheets for review and quality assurance
• Provided detailed progress reports to study leadership and international partners 3+ times per month to ensure timely communication
• Collaborated with other researchers to develop successful research strategies.
• Recorded and analyzed data to produce reports of results.

• Conducted 100,000+ microbiological tests, and processed 250,000+ viral load samples.