Experience

FHI Clinical Inc.

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Clinical Research Associate I

  • May 2023 - Present

  Assists in the preparation of routine protocols, informed consent/assent forms, SOPs, and other appropriate study documentation. Monitors clinical trials to ensure subject safety and compliance with the study protocol, applicable regulations and ICH/GCP Guidelines, may be done with supervisor. Coordinates activities required to set-up, monitor, and close-out clinical trials sites. Conducts site evaluation/assessment, initiation, routine, and close-out monitoring visits. Completes accurate monitoring visit reports. Develops training materials and conducts training for study implementation based on company policies and SOPs. Contributes to the development of and implements protocols and informed consents/assents for research studies. Provides guidance on any protocol related issues. Manages budget to ensure CRA activities are completed as per contract. Develops, reviews, and maintains key study documents. May serve as a liaison with internal and external partners to ensure effective collaboration efforts. Oversees planning of meetings, site visits, and drafting necessary documents. Ensures compliance with applicable government regulations when writing and reviewing protocols, analysis plans, reports, and manuscripts. Provides input with CRF development, analysis, study design, and material management. Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, applicable regulations and FHI Clinical SOPs. Conducts site visits to assess protocol and regulatory compliance and manages required documentation. Updates and maintains study specific tracking tools. May function as project manager on assigned projects. Responsible for ensuring that data will pass international quality assurance audits. Represents FHI Clinical in the global clinical research community and develops and maintains collaborative relationships with investigational sites and clients. Show less



Kenya Medical Research Institute (KEMRI)

• Kenya
• Research Services
• 700 & Above Employee

• Consulting monitoring for FHU

  • Jan 2021 - Apr 2023

  Assisted a sister site in KEMRI in quality and regulatory preparatory work by reviewing recruitment plans, providing mentorship to the regulatory and quality assurance officers, Provided Good Documentation training, Ethics Training and Good Clinical Practice training. Reviewed Informed Consent forms and source notes, issued reports and provided guidance on how to resolve findings. Helped team develop training trackers. Provided guidance on how Corrective and Preventive Action plans. Assisted a sister site in KEMRI in quality and regulatory preparatory work by reviewing recruitment plans, providing mentorship to the regulatory and quality assurance officers, Provided Good Documentation training, Ethics Training and Good Clinical Practice training. Reviewed Informed Consent forms and source notes, issued reports and provided guidance on how to resolve findings. Helped team develop training trackers. Provided guidance on how Corrective and Preventive Action plans.



KENYA MEDICAL RESERARCH INSTITUTE CENTER FOR GLOBAL HEALTH RESEARCH (KEMRI/CGHR)

• Kisumu County, Kenya

• INTERNAL MONITOR/CLINICAL RESEARCH SITE COORDINATOR AT KISUMU CLINICAL RESEARCH SITE, KEMRI CGHR

  • Jul 2017 - Apr 2023

  Reviewing protocols and determining site’s capability to participate in (in terms of population vs demographic characteristics, sample size determination vs disease burden, general infrastructure-laboratory, pharmacy capacity) Participates in site selection and site initiation meetings • Conducting internal audits/ internal monitoring as per Clinical Quality Management Plan (CQMP). Singe designated staff who performs internal audits and internal inspections for the studies twice a year. Responsible for creation of QA related SOPs, reviewing applicable CRS SOPs and approving applicable SOPs and responsible for tracking calibration timelines for equipment and maintains documentation including SOP. Ensuring all SOPs are tracked and periodically reviewed. Conducting biannual audit on SOPs to assure compliance. Conducting trainings Following up of identification of adverse events, reporting and linking with study endpoints Monitoring site’s data performance and working with the teams to ensure that the network metrics are met and action plans done and implemented to the latter. Follows up to ensure adverse events and serious adverse events are properly documented and reported in a timely manner. Show less



KEMRI\CDC TB Branch

• KISUMU

• Regulatory/Quality Assurance/Training Manager

  • Jan 2008 - Jun 2017

  Conducted and coordinated trainings, heading training section Identify staff education, training and development needs Ensured educational and training support for implementation of research studies. Trained staff on relevant protocol procedures Monitored study team compliance with required study procedures and GCP standards • Assisted in monitoring, documenting and reporting adverse events to Institutional Review Boards and Sponsor. Performed timely submissions to the Scientific and Ethics review unit SERU and regulatory body KPPB Maintained essential documents as required by regulatory agency guidelines. • Oversaw data entry for specific visit on CRF; audit records for accuracy, and ensure completed CRFs. Audited documents and files and prepare for archival storage. Maintained personnel training records Maintained records of all communications between the IRB/EC and the study team regarding this study. • Reviewed all IRB / IEC correspondence files to ensure completeness and adherence to SOP Oversaw quality control (QC) and quality assurance (QA) procedures related to various SOP. Ensured confidentiality and data quality. Held regular meetings with study staff to discuss problems with documents and their organization Show less