Kgopolo Ngake

Public Health graduate with an undergraduate degree in Clinical Medical Practice. I have strong healthcare, administrative, data management, and quality assurance experience gained through clinical training and academic projects. Skilled in maintaining accurate records, coordinating workflows, compiling reports, managing databases, and communicating with multidisciplinary stakeholders.

Demonstrates exceptional attention to detail, organizational skills, and commitment to compliance with policies, procedures, and quality management systems. Eager to contribute to the South African Health Products Regulatory Authority (SAHPRA) through effective administrative support, evaluation coordination, and regulatory process management.

Clinical Research Coordinator/Clinical Associate - Tsitsikamma Clinical Research Initiative

(2025-01 - 2025-12)

Coordinated daily clinical trial activities, participant recruitment, enrolment, and retention.

• Managed informed consent, study documentation, CRFs, and Electronic Data Capture systems.
• Maintained regulatory files and supported ethics and regulatory submissions.
• Performed data verification, query resolution, adverse event reporting, and safety monitoring.
• Coordinated communication between investigators, sponsors, monitors, and study teams.
• Supported audits, monitoring visits, quality control reviews, and study close-out activities.
• Maintained high standards of regulatory compliance, data integrity.
• Quality assurance across multiple clinical studies.

Clinical Associate - SAMRC

(2024-10 - 2024-12)

Managed participant documentation, informed consent records, and study data.

• Maintained regulatory files and supported safety reporting activities.
• Ensured compliance with study protocols and GCP requirements.
• Achieved complete and accurate maintenance of study documentation.
• Contributed to quality assurance processes supporting participant safety and data quality.

Post Graduate in Public Health - Public Health - University of Pretoria - Health Sciences (2024-04 - 2025-12)

Bachelor of Clinical Medical Practice - Clinical Medical Practice - University of Pretoria - Health Sciences (2019-02 - 2021-12)

Grade 12 - Science Stream - Ndzundza Mabhoko Secondary School (2010-01 - 2012-12)