Roselyne Omolo

Roselyne Omolo

Nursing Officer Intern

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  • Timeline

  • About me

    Director of Programs

  • Education

    • University of Nairobi, KAVI

      2023 - 2023
      CERTIFICATE IN CLINICAL TRIALS MONITORING COURSE CLINICAL TRIALS MONITORING CERTIFICATE OF COMPLETION

      Activities and Societies: Modules covered: Introduction to Clinical Research, Drug discovery and development, ICH GCP, Data management, Study design, Trial Site feasibility, Site initiation, Interim and Risk based Monitoring, Quality management, Patient safety, Site management, Monitoring plan, Investigation product management, Technology in Clinical Research, Clinical research laboratories, Human Subjects Protection. Patient recruitment, budget and contract management, ethics in clinical research.

    • Kenyatta University

      2017 - 2020
      Master of Business Administration - MBA Project Management
    • Moi University

      2010 - 2014
      Bachelor of Science - BS Nursing Science
  • Experience

    • Ministry of Health, Kenya

      May 2015 - Apr 2016
      Nursing Officer Intern

      • Provided general, obstetric, psychiatric and paediatric nursing services.

    • LVCT HEALTH

      Sept 2016 - Aug 2017
      Study Nurse, Key Polpulation Program

      • Screening and enrollment of MSMs and FSWs into the study from both on site clinic visits and snow balling references by other enrolled clients.• Working with the coordinator to ensure study SOPs and updated Protocols were readily available for reference at site.• Ensured that patient documents were kept safe to ensure confidentiality.• Ensuring that all clients in the study signed consent forms and that they met the study eligibility criteria.• Assigning different colour codes to the different sub types of the populations for ease of retrieval and use while liasing with the data office.• Provision of comprehensive reproductive services including STI treatment to the FSWs, MSMs and PWIDs after enrollment into the study.• As a member of the continuous quality improvement team in the facility, took a lead role in formation of work improvement teams(WIT) to ensure quality control and quality assurance of all the services that were offered.• Preparing departmental budgets and requisitions. Show less

    • American International Health Alliance

      Sept 2017 - May 2019
      Program Officer, Biomedical Options

      • Coordinating and providing technical assistance through trainings, mentorship and support to staff in the health facilities, community health volunteers and community health extension workers in matters biomedical interventions.• Building the knowledge and capacity of affiliated partner organizations and groups such as local school faculty, CSOs, CBOs and engaged lay workers in available options.• Conducting site-level (Community health facilities) and schools, support supervision and mentorship to ensure the interventions were being implemented per individual intervention SoPs and in tandem with the MoH guidelines.• Overseeing interventions M&E ctivities while liasing with the MERL lead to measure progress and to systematically assess the meeting of intended objectives in order to draw trends, thus inform programs.• Supporting in guidance of documentation while ensuring data was properly captured and reported per donor intervention guidance.• Working with the CHMTs, SCHMTs, facility in charges through operational planning meetings, community liaisons, data review meetings, trainings, on job mentorship and supporting facility level CMEsto ensure program objectives were met.• Working alongside other technical staff and partners to develop and maintain program work plans in line with the Gannt chart, making changes and updates appropriately.• Representing the organization at USG Implementing Partner’s meetings, TWG meetings and other stakeholder meetings as required.• Serving as an information source on program policies, procedures and administration guidelines. Show less

    • Kenya Medical Research Institute (KEMRI)

      Jun 2019 - now
      Regulatory Affairs, Ethics and Quality Assurance Coordinator

      • Leading development and maintenance of Study Master File/ Investigator Site Files.• Preparing study sites for external monitoring visits (selection, qualification, initiation, monitoring and close-out visits) and writing post visit reports.• Acts for and on behalf of the Principal Investigator with regards to regulatory compliance.• Manage the progress of the studies by tracking regulatory submissions and approvals, recruitment and enrollment, e CRF completion and submission, and data query generation and resolution• Works together with the study coordinators /HoDs in ensuring timely submissions to KEMRI SERU/ PPB/ NACOSTI.• Oversee maintenance of Trial Master Files and Investigator Site Files.• Maintaining up to date regulatory binders for the study including the Study Master Files, essential documents, delegation of duties logs, training files, stakeholder engagement memoranda and minutes.• Planning and conducting internal site monitoring for the study and following up on proposed action plans.• Working with external monitors during monitoring visits and spear heading resolution of monitoring visit clarification forms.• Coordinating and documenting study related internal trainings/ curricular.• Active role in the development and review processes for study SOPs.• Checking and ensuring regulatory compliance by all departments of the various studies under the SEARCH Consortium, i.e SEARCH MAIN , SEARCH YOUTH, SAPPHIRE, VIRAEMIA RISK SCORE, DTG, OPAL, CKD and ACTION Studies.• Working with the clinic teams on Protocol deviations/violations and SAE/ UAE/ SUSAR identification and reporting, especially with regards to maintenance of central and site logs and filing of reports.• Working with the respective departments on implementation of the Studies’ Quality Management Plans• Other duties as delegated by the Study Managers/Principal Investigator. Show less

    • Kenya Hospices and Palliative Care Association (KEHPCA)

      Jul 2024 - now
      Director of Programs
  • Licenses & Certifications

    • Research Ethics Evaluation

      Training and Resources in Research Ethics Evaluation
      Feb 2023
    • ROSELYNE AWINO OMOLO

      NURSING COUNCIL OF KENYA
      Jul 2023
    • Introduction to Data Management for Clinical Research Studies

      CITI Program
      Oct 2023
    • ICH-GCP

      CITI Program
      Jan 2021
    • Improving Health Care Through Clinical Research

      The Global Health Network
      Nov 2023
    • How to Conduct GCP Inspection/Audits at the Clinical Investigator Site

      The Global Health Network
      Oct 2023
    • Clinical Research Operations for Study Coordionators

      The Global Health Network
      Feb 2023
    • Introduction to Collecting and Reporting Adverse Events

      The Global Health Network
      Oct 2023
    • Human Subject Protection

      CITI Program
      Jan 2021
    • Ethics and Best Practices in Sharing Individual Level Research Data

      The Global Health Network
      Oct 2023