Ambrose Balikuddembe

Connections 28

Clinical Trail’s QC/QA Manager at The Uganda – CWRU Research Collaboration

since July, 2023

am***be@gmail.com

Skills

Recommendations

ssempeebwa David

5/30/2024

"Very dedicated to working with others "

Experience

Ambrose Balikuddembe

Work experience

Clinical Trail’s QC/QA Manager at The Uganda – CWRU Research Collaboration

July, 2023 -
Fulltime

As QC/QA Manager for Research Collaboration, my primary objective is to Monitoring the clinical trial to adhere to Protocol, observation of the MOOP QMP, Recruitment Plan, SOPs, GCP-ICH guidelines and Regulatory requirements. Observation of Good Documentation Practices for the realization of credible, reliable and accurate data while embracing ALCOA and, proper Informed Consenting process documentation for the participants’ safety and wellbeing. My duties include activities aimed at maintaining quality throughout the research process, managing and implementing quality control and assurance measures for the various aspects of clinical trials within the collaboration, ensuring adherence to policy, regulatory requirements and best practices;
Internal QA Development and Implementation;
 Establish and execute a quality control process for collaborative trials
Ensure data validity by evaluating CRF entries for; Completeness, Accuracy, and Legibility
Assure the site’s adherence to protocol and ICH: GCP, SOPs, and MOOP,
All regulatory documents in the investigator file are current,
The Storage of study Drugs and accountability proper?
Train site staff
Source Data Verification (SDV)
Data review
SDV for Eligibility
SDV of the Adverse Events (AEs)
SDV for Blood sample collection, processing storage, and transportation
SDV of the Concomitant Medication Form
SDV for Drug Accountability
SDV for Lab Results
CAPA Resolution for Monitoring reports
▪ Regularly provide feedback on QA findings to relevant stakeholders such as the Principal PI, study supervisor, medical staff, nurses and staff.
Collaboration and Coordination;
▪ Liaise with Study Coordinators and Regulatory Coordinators to manage ongoing QA, QI, and QC activities.
▪ Ensure the utilization of the most current versions of essential study documents in all collaboration activities.
▪ Coordinate training sessions for collaboration staff on QC, QA, and QI activities.
Plan Development and Review:
▪ Develop, implement, and refine QA, QI, and QC plans and tools for new collaboration studies as necessary.
▪ Review and update all QA, QI, and QC plans annually or as required.
SOP Compliance and Site Coordination;
▪ Develop, review and update local SOPs for site trials.
▪ Ensure compliance with general and subject-specific SOPs.
▪ Coordinate site response to quarterly TBTC QA reviews for ongoing trials.
▪ Set up error mitigation plans for TBTC studies.
Inspections and Reviews:
▪ Perform on-site mock inspections in preparation for possible regulatory inspections