David Kiiza
Entebbe
Summary
Experienced Clinical Research Professional with more than 8 years of hands-on experience that includes collecting regulatory documents, initiating and monitoring study sites, performing interim monitoring, and completing study close-out visits. Thoroughly dedicated to conducting studies in accordance with good clinical practices, study-specific criteria, and clinical monitoring plans.
Overview
9
9
years of professional experience
Work History
Study Coordinator
UVRI-IAVI HIV Vaccine Program
Entebbe
08.2022 - Current
- Conduct initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Participate in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Work with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Review participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Follow drug storage procedures to comply with protocols and SOP requirements.
- Collaborate with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Review data queries and listings and works with study centers to resolve data discrepancies.
- Review clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Maintain site monitoring schedules to facilitate effective communication with members of clinical team.
- Monitor safety of human subjects and oversees consent procedures to comply with local and international regulations.
- Mentor team members through weekly virtual meetings.
Quality Assurance Manager
UVRI-IAVI HIV Vaccine Program
Entebbe
04.2018 - Current
- Conduct quality audits to ensure compliance with GCP and IRB standards.
- Review adverse events and serious adverse events reports and documentation.
- Verify informed consent forms, eligibility criteria, study visits, missed visits and investigational product administration for each subject.
- Check CRFs and source documents for accuracy and consistency.
- Document and communicated errors and discrepancies to the site staff and the sponsor.
- Review investigational product accountability records and storage conditions.
- Review regulatory files and essential documents for completeness and currency.
- Prepare quarterly quality review reports and tracked CAPA completion for non-conformities.
- Ensure daily QA/QC operations were performed according to SOPs.
- Ensure personnel training files were updated with relevant trainings and competencies.
- Ensure SOPs were current and in use, and maintained a master list of SOPs and documents.
- Coordinate external audits and trained staff on quality management, SOPs and study documents.
- Perform risk assessment and correspondence with sponsors or their representatives.
Clinical Trial Documentation Assistant
Access Pharma Group, Montreal
Montreal
01.2022 - 09.2022
- Learned and adapted quickly to new technology and software applications.
- Created CRF modules and document templates for the affiliated SMO.
- Developed SOPs for the Clinical Operations.
- Provided professional services and support in a dynamic work environment.
Clinical Research Associate Intern
CRA School of Montreal
Montreal
06.2021 - 01.2022
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Demonstrated creativity and resourcefulness through the development of innovative solutions.
- Skilled at working independently and collaboratively in a team environment.
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
- Conducted remote monitoring.
- Performed; Protocol Synopsis & Analysis, CRF design & completion Data Entry, Query resolution, Identification of protocol violations, TMF Organization, AE/SAE reporting, Regulatory and IRB Submissions, Site Selection, Site Management, Source Data Verification and Review, EDC/CTMS-Datatrak and Fraud detection.
- Created; IND/CTA, IB, CRF SQV, SIV, IMV & COV checklists and Confidentiality Agreements.
Medical Laboratory Technologist
UVRI-IAVI HIV Vaccine Program
Entebbe
05.2014 - 04.2018
- Utilized expertise in microbiology, chemistry, and hematology to help with diagnosis of medical issues.
- Kept laboratory in compliance with applicable guidelines and laws.
- Processed participant specimens according to priority and documented results.
- Maintained confidentiality of all patient information to conform to internal, and other regulatory standards.
- Utilized advanced technologies to identify and analyze complex medical samples.
- Performed routine maintenance and calibration of laboratory equipment to produce accurate results.
- Trained and supervised new laboratory staff to improve skills in laboratory procedures.
- Assisted with laboratory research projects to advance knowledge and discovery in healthcare.
- Participated in laboratory audits and assessments to maintain compliance and improve results.
Education
Advanced Certificate - Clinical Trial Operations
CDT-AFRICA
Addis Ababa, Ethiopia02.2022
MBA - Health Management
UNICAF University
Lusaka, Zambia01.2022
Diploma - Certified Clinical Research Professional
CRA School of Montreal
Montreal, Canada01.2022
Bachelor of Science - Medical Laboratory Science
Mbarara University of Science And Technology
Mbarara, Uganda02.2013
Skills
- ICH GCP, FDA regulations and GCLP
- Clinical Trial Conduct & Monitoring
- Site Evaluation, Selection and Initiation
- Report writing
- Volunteer Recruitment Strategies
- Study Coordination
- Project Management
- EDC-Medidata Rave, Datatrak
Timeline
Study Coordinator
UVRI-IAVI HIV Vaccine Program
08.2022 - Current
Clinical Trial Documentation Assistant
Access Pharma Group, Montreal
01.2022 - 09.2022
Clinical Research Associate Intern
CRA School of Montreal
06.2021 - 01.2022
Quality Assurance Manager
UVRI-IAVI HIV Vaccine Program
04.2018 - Current
Medical Laboratory Technologist
UVRI-IAVI HIV Vaccine Program
05.2014 - 04.2018
Advanced Certificate - Clinical Trial Operations
CDT-AFRICA
MBA - Health Management
UNICAF University
Diploma - Certified Clinical Research Professional
CRA School of Montreal
Bachelor of Science - Medical Laboratory Science
Mbarara University of Science And Technology
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