ELIZAPHAN OGIK OLOO

• Conduct site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct
• Interact with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues and assigned sites
• Perform drug accountability to ensure adequate use and storage of investigational drugs
• Understand study timelines and manage sites to meet timelines
• Collaborate with team to maintain consistent CRF data quality and discrepancy resolution across sites within the stipulated timelines
• Pro-actively identify and work to resolve enrolment and data completion issues
• Perform manual, in-house review of CRF data in clinical database (EDC) for completeness and accuracy prior to site visits
• Review regulatory documents from study sites and Investigator Site Files to ensure completeness and accuracy
• Ensures study records are complete and auditable during monitoring visits at investigational sites
• Communicate status of trial to manager and project management team
• Prepares monitoring reports per SOPs and submit reports in the clinical trials management system within timelines.

Protocols

• Phase I Trial of Repurposed Unithiol for snakebite Envenoming (TRUE-1).
• A phase IV double blinded, randomized, controlled Non- Inferiority Fractional-Doses Trial for Yellow Fever Vaccine (NIFTY)-Uganda.
• Pancreatic enzymes and Bile Acids: A Non-Antibiotic approach to treat Intestinal Dysbiosis in Acutely III Severely Malnourished Children (PB-SAM).
• Safety, immunogenicity, and efficacy of R21/Matrix-M and ChAd63/MVA-ME TRAP in the context of controlled human malaria infection Phase IIb trial in Kenyan adults (VAC074).
• Phase II Multi Centre Gastroenteritis Rehydration of Children with Severe Acute Malnutrition (GASTROSAM).

Key responsibilities.

• Developed monitoring plans for ongoing studies in the unit as per ICH/ GCP and regulations within the program.
• Performed site initiation visits as per the monitoring plan. Initiation visits to include pharmacy and other facilities as needed to confirm delivery of study materials, documents, Investigational Products and to ensure the study team understands protocol, SOPs, and ICH GCP requirements and that the facilities including laboratories, equipment, and staffs are adequate to conduct the trial.
• Monitored clinical trials progress through a combination of risk-based monitoring, off-site, central monitoring, and on-site monitoring visit.
• Performed routine monitoring visits and ensure that studies are conducted according to protocol, SOPs, ICH GCP, and other applicable regulations to ensure the safety of participants and quality of data as defined in the clinical quality management plan.
• Verified that the trial data are consistent with patient clinical notes and other source documentation (source data verification/review).
• Ensured the sponsor, investigator, and study team adhere to current regulations, ICH/GCP, SOPs, and local policies in place.
• Verified adequacy of site staff experience and training, coordinate additional training as needed including ICH GCP, Protocol, and SOPs.
• Adhered to monitoring plan, and protocols e.g., monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms, risk-based monitoring tools, and other templates.
• Created and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation.
• Provided recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
• Participated in regular monitoring team group meetings and training of upcoming monitors including a mentorship approach.

• Protocols
• A phase Ib/II single-blinded, randomized, controlled study to determine safety, immunogenicity and efficacy of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 n CoV-19 in adults in Kenya (COV004)
• A phase IV double blinded, randomized, controlled Non- Inferiority Fractional-Doses Trial for Yellow Fever Vaccine (NIFTY)
• A Phase IV Randomized, Double Blinded Non-Inferiority Trial on the Immunogenicity and Safety of Fractional Doses of Yellow Fever Vaccines (YEFE)
• Estimating the transmission and case burden of Zika virus in Kenya

Key Responsibilities

• Ensured the trials are delivered within time, budget, and scope while ensuring trial participant rights, safety and wellbeing are the number one priority and that the data generated by the trials are accurate and verifiable
• Developed study documents such as Case Report Forms (CRFs), Manual of Operations (MOP), Study Specific Procedures (SOPs), Clinical Quality Management Plans (CQMP), Monitoring Plans, and Study Specific Logs among others
• Facilitated protocol training and ensure protocol adherence across all sites both onsite and remotely
• Managed a multidisciplinary project team requiring interaction with internal and external groups including clinical science, data management, pharmacovigilance, regulatory affairs, quality assurance, procurement, and shipping logistics
• Interacted with different stakeholders including the Ministry of Health, sponsors, and external monitors regarding the Vaccine trials
• Generated regular quality project reports, implement mitigation plans where need be, and escalate any major issues as required
• Implemented any recommended corrective actions as needed to maintain project performance
• Streamlined effective quality assurance measures for the studies for successful completion of the studies such as ensuring internal audits on the study data and procedures are conducted and developing documents such as the Clinical quality management plan and Standard operating procedures for use within the trial
• Monitored all project plans weekly to ensure all trials adhere to any set timelines
• Conducted regular meetings with the project team, reviewing project outputs and outstanding action items
• Provided regular summary reports to the trial management group, regulatory and Ethics review bodies, and sponsor as required
• Set up and maintained the trial master file (TMF) both electronic and hard copy
• Trials registration on an online trial registry e.g., Pan African Clinical Trials Registry (PACTR), Clinical- Trial.gov, etc., and ensured updates are made whenever necessary
• Communicated with ethics, regulatory authority, and other stakeholders on trial close out and submited all required reports.

Key responsibilities

• Screened participants and identified those that meet the surveillance case definition as per protocol
• Consented, enrolled eligible participants into the study, and administered enrolment questionnaire to consenting participants
• Verified participants are eligible for specimen collection and abstracted hospitalization course information
• Managed the AFI logbook for enrolment, sample collection, and safely stored participant data as per surveillance protocol
• Managed site supplies, equipment at the site and provided weekly updates of each site operation to the surveillance coordinator
• Created and maintained a good rapport with other staffs at the health facility and patients to ensure the success of the surveillance
• Served as the point of contact for PI, study coordinator at the site, and provided insight and guidance for surveillance implementation at the site
• Participated in the interpretation of surveillance results and assisted with troubleshooting for challenges that arise at the site
• Served as representative of the AFI surveillance team for the hospital leadership with local health authorities.

Key responsibilities

• Located eligible households and household respondents
• Recruited, screened, and enrolled participants and conducted the necessary study procedures for the participants
• Collected accurate data from the study participants using REDCAP in line with the standards of operation set in the study protocol
• Provided sample collection supplies to household participants and instructed them on the correct sample collection procedures as detailed in the field manual
• Reviewed data to ensure completeness and accuracy of the information and uploaded the data that has been collected electronically using the tablets
• Correctly labeled and packaged samples for transportation to the KEMRI-KISIAN laboratory
• Corrected any omission or inconsistency by revisiting the household members and asking for the required information
• Accurately filled out sample tracking and transportation log forms
• Maintained the security and confidentiality of all survey documents and information
• Kept track of study supplies and reporting deficits to the team lead
• Reported and discussed any challenges concerning the study noted in the community with the study coordinator and addressed the arising issues
• Completed other tasks assigned by the Data manager and Study coordinator.

• Responsibled for screening, examining, and enrolling participants in the study and conducting follow-up appointments with participants and Caregivers
• Performed physical exams, collecting health history, and ascertain other relevant information from caregivers using standardized case report forms
• Submitted weekly reports to the study coordinator summarizing indicators of study progress and communicated challenges and successes to the study coordinator
• Tracked and maintained relevant clinical systems to ensure fidelity to project timelines and other compliance requirements.
• Developed in-depth understanding of the study goals and the logistics involved in the study. Carried out medical and neurological examinations, interpreted laboratory results.
• Treated Medical conditions that the study participants may presented with.
• Offered high quality and integrated HIV services in accordance with study protocol and national guidelines and policies including HTS, care and treatment, patient monitoring, family planning and PMTCT among others.
• Managed cases of non-Communicable diseases at the study site and followed up of the cases as per national guidelines.
• Coordinated study operations at the site and ensured that the study regulations are adhered to, and objectives are met at the site.
• Coordinated and participated in the data analysis and report writing activities and preparation of study research reports