OTUOMA ANTONINA ATIENO

• Orchestrated site initiation and protocol implementation, resulting in a 20% increase in study management efficiency through streamlined processes.
• Provided comprehensive administrative and technical support to field and data management teams, leading to a remarkable 30% boost in participant recruitment and ensured timely study close-outs.
• Successfully supervised day-to-day study activities and conducted supervision visits, contributing to a 25% reduction in operational challenges, ensuring smooth study execution.
• Coordinated site investigations, documented issues, and escalated to executive teams.
• Implemented protocols and procedures to effectively manage planning process.
• Fostered positive site and community relations, promoting a collaborative and supportive environment for study activities.
• Develop community engagement related processes, including SOPs, work instructions and tools/templates.
• Act as Community Engagement Lead, provide community engagement updates to project team meetings and donor reports.

• Elimination of mother to child transmission as per the National guidelines using the four prongs; primary prevention of HIV infection and other comorbidities among women of child bearing age
• Prevention of unintended pregnancies among HIV positive women
• Prevention of HIV transmission from positive mothers to infants
• Continuous care and treatment for infected mothers, partners and children.
• Assessed patients to determine individual needs and develop care plans in coordination with multidisciplinary healthcare professionals.
• Remained calm during high-stress, critical situations, demonstrating sustained focus and problem-solving in real-time.

A randomised study comparing IPTp-SP and IPTp-DP for better alternatives and help in policy decisions for the prevention of malaria in pregnancy and improve birth outcomes

• Contributed to a 25% reduction in query resolution time by addressing queries with meticulous attention to detail, aiding in the formulation of a comprehensive clinical quality plan.
• Achieved a 98% accuracy rate in data validation by conducting thorough reviews of case report forms, case notes, participant eligibility criteria, as well as initial and final Serious Adverse Event (SAE) reports.
• Enhanced protocol integrity by 20% through scrutiny of consent forms and processes, ensuring full compliance with Good Clinical Practice (GCP) documentation requirements.
• Played a pivotal role in improving the efficiency of clinical quality processes by contributing to the formulation of a comprehensive clinical quality plan.
• Consistently met and exceeded quality standards by ensuring compliance with Good Clinical Practice (GCP) documentation requirements and maintaining a high level of data accuracy throughout the process.

• Provide and ensure continuity of care of patients
• Providing leadership to the unit’s personnel and nursing students in their clinical rotations
• Representing the unit in hospital management team with aims of improving services
• Preparing and submitting reports.
• Demonstrated strong organizational and time management skills while managing multiple projects.
• Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
• Demonstrated creativity and resourcefulness through the development of innovative solutions.

• A random study under IEIP surveillance that was comparing the number of people with pneumococcal bacteria before and after introduction of PCV therefore providing information on direct and indirect effects to improve on decision making of the ministry of health
• Responsible for day to day study activities such as screening for eligibility, registration, giving informed consent, filling out questionnaire, review of the vaccine card, sample collection, verification, storage and transportation of samples to the main lab in Kisian, on a daily basis
• Achieved a 20% increase in trial completion efficiency by acting as the primary liaison for study sites, effectively coordinating and managing trials to successful completion and publication.
• · Ensured 100% compliance with comprehensive CRFs, SOPs, and manuals aligned with ICH-GCP, study protocols, and local regulatory requirements, resulting in enhanced protocol adherence and streamlined processes.
• Enforced strict adherence to study protocols, ICH/GCP guidelines, and applicable regulations among study staff, leading to a remarkable 95% protocol compliance rate and validating the integrity of study data.
• Maintained a high level of compliance and adherence to regulatory standards by consistently monitoring and enforcing protocol and guideline adherence, contributing to the successful and ethical conduct of clinical trials.
• Streamlined and optimized trial management processes by enforcing compliance, ensuring that study staff consistently followed study protocols, ICH/GCP guidelines, and applicable regulations, ultimately contributing to the integrity of study data and regulatory compliance