Judith Omungo Email & Phone Number

Nairobi County, Kenya

Nairobi County, Kenya

I specialize in driving the efficient launch of clinical trials by overseeing the regulatory and site activation process. I manage the preparation and submission of essential documents, navigate complex regulatory landscapes, and ensure compliance with local and global guidelines. By collaborating with ethics committees, regulatory bodies, and investigative sites, I accelerate approvals and streamline start-up timelines. I also support contract and budget negotiations, helping to align all stakeholders for a smooth trial initiation. My goal is to deliver faster, compliant solutions that help bring life-changing therapies to patients sooner.

Nairobi

• Actively review various components of research process to assess adherence to protocols, Good Clinical Practice (GCP), Human Subject Protection (HSP), and Applicable guidelines to determine the accuracy of research records. • Assist with site preparations for visits by external monitors where necessary at various study sites during site initiations, interim and close-out monitoring visits.• Review regulatory folder periodically; Trial Master File (TMF) and assist in tracking of regulatory submissions for new and active studies. • Ensure that the submission package is complete and of high-quality using submission checklist before submission to the regulatory and ethics committee.• Providing internal audits of study documents: Informed Consents (ICFs), Case Report Forms (CRFs) in accordance with Division of Aids (DAIDS) requirements of Clinical Quality Management Plan (CQMP).• Develop, direct and coordinate a quality assurance/ quality control (QA/QC) activities for all the study sites• Ensure patient confidentiality by ensuring patient CRFs is well handled and stored.• Carry out QA/QC on Study Informed Consent Forms (ICFs) and CRFs to ensure completeness, Integrity and consistency.• Assist in drafting of tailored CRFs, ICFs, SDs and Standard operating procedures (SOPs)• Respond to study queries within the timelines stipulated by the protocol and SOPs• Support field staff in establishment of work priorities related to data, schedules and goals.• Generate reports / updates on QA/QC activities including Adverse events reporting (AEs) to Study Principal Investigators (PIs)•Training staff on Research Ethics and Good Clinical Practice (GCP)•Provide inventory of study materials to ensure constant and efficient supply to study sites.

Remote and Centralized Monitoring Training Course. •Successfully completed the rigorous Clinical Research Associate program at Viares Academy, gaining comprehensive knowledge and skills in the field of clinical research.• Developed a strong understanding of Good Clinical Practice (GCP) guidelines, FDA regulations, and industry standards.•Acquired expertise in clinical trial management, including study design, protocol development, and patient recruitment.•Learned essential skills in data collection, monitoring, and analysis, ensuring accuracy and compliance with study protocols.• Received training on the ethical considerations, informed consent procedures, and protection of human subjects in clinical trials.• Familiarized with the essential elements of study start-up, site initiation, and study closeout activities.• Gained practical experience in conducting site visits, maintaining trial documentation, and ensuring regulatory compliance.•Collaborated with cross-functional teams, including investigators, sponsors, and study coordinators, to ensure seamless trial execution.•Acquired knowledge of adverse event reporting, safety monitoring, and pharmacovigilance processes.

Thika, Kiambu, Kenya

-Review and prepare protocol and amendment application to the KEMRI Scientific and Ethics Review Committee,(SERU),the Kenya Pharmacy and Poisons Board(PPB) and the National Commission for Science, Technology and Innovation(NACOSTI).Monitor and follow up study participants and report any Adverse Events( AE),Severe Adverse Events (SAE).-Managing data integrity by implementing relevant SOPS and documentation practice, reviewing data and identifying discrepancies and implementing corrective actions daily.-Management of data using DFNet, ODK, Dashboard and REDCAP data applications.Counselling of the study subjects on the expected reactions to vaccines, information on self care, and participants provided with site contact numbers, asked to report new local and systematic symptoms that arise after they leave the study site.-Defaulter tracing conducted to reach the participants that are not able to come to the clinic and cannot be reached on phone. -Conducting offsite visits to collect clinical trial samples to the participant who consented for offsite sample collection.

Key achievements include:• Appointed as study coordinator of an observational pilot study and characterized the immune response induced by the commercial varicella zoster in healthy adult females in Nairobi.• Operated as Biosafety committee member and engaged in establishment of safety policies while reviewing and following up on safety audit reports, and rendering internal training for staff on safety issues.• Provided information on research projects to potential study participants.• Performed complex nursing procedures, including patient assessment, specimen collection, intravenous infusions, interpretation and evaluation of patient status and needs.• Screened and recruited subjects for various clinical studies, Maintained confidential files, regulatory documents and completed all case report forms in compliance with NIH, FDA and HIPAA guidelines• Assisted principal investigators with protocol reviews, IRB applications, annual reports, budget preparation, internal billing and external publication processes.• Maintained study documentation, including completing case report forms, and creating study information material• Generated and drafted nursing reports as may be required from time to time.• Remotely Supported study Coordination activities for ongoing studies.

Bachelor Of Science In Nursing, Nursing Science

Advanced Pg Diploma In Clinical Research & Regulatory Affairs, Clinical Research

Diploma,Kenya Registered Community Health Nursing.

Certificate In Clinical Research Associate,, Clinical Trials