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Ruth Mekgor

@ruthmekgor

Regulatory and Compliance Officer at Wits Health Consortium, improving regulatory tracking and submission processes for clinical research studies.

South Africa
Message

At Wits Health Consortium – Isango Lethemba TB Research Unit, I establish and maintain regulatory systems and coordinate submissions to Ethics Committees, SAHPRA, sponsors, and other regulatory authorities. I’ve improved regulatory tracking and submission processes and supported regulatory maintenance across multiple research studies.

At Synergy Biomed Research Institute and Setshaba Research Centre, I coordinated clinical studies from initiation through close-out and managed regulatory and ethics applications. I also supported patients using eCOA platforms, including device setup and troubleshooting.

At Setshaba Research Centre, I coordinated clinic operations, participant flow, scheduling, and study documentation as a Research Administrator. I also produced study projections and operational reports.

My clinical research training includes Ethics & Good Clinical Practice (GCP), Clinical Research Quality Control, and Clinical Research Coordination. I’m completing a Bachelor of Commerce in Human Resource Management at the University of South Africa (UNISA).

Experience

Work history, roles, and key accomplishments

Wits Health Consortium logoWC
Current

Regulatory and Compliance Officer

Wits Health Consortium

Jan 2024 - Present (2 years 9 months)

Established and maintained regulatory systems for clinical studies, coordinated submissions to Ethics Committees and SAHPRA, and managed Investigator Site Files and essential documentation. Developed SOPs, supported informed consent processes, and prepared teams for audits and inspections.

SI

Study Coordinator & Regulatory Officer

Synergy Biomed Research Institute

Jan 2022 - Dec 2023 (1 year 11 months)

Coordinated study activities from initiation through close-out, prepared regulatory and ethics applications, and maintained compliant Investigator Site Files. Acted as primary liaison between investigators, sponsors, CROs, and regulatory authorities, and managed eCOA platforms and site staffing.

SC

Study Coordinator & Regulatory Officer

Setshaba Research Centre

Jan 2020 - Dec 2022 (2 years 11 months)

Coordinated all operational aspects of clinical trials, managed regulatory submissions and correspondence, and oversaw study staff training and compliance with ICH-GCP. Developed and implemented SOPs, ensured accurate documentation, and supported participant retention and community engagement.

Education

Degrees, certifications, and relevant coursework

University of South Africa logoUA

University of South Africa

Bachelor of Commerce, Human Resource Management

Pursuing a Bachelor of Commerce in Human Resource Management with an expected completion in May-June 2027. Six modules remaining.

AA

Academic Advance

Certificate, Information Privacy

2025 - 2025

Completed POPIA Information Session in 2025.

AA

Academic Advance

Certificate, Quality Control

2025 - 2025

Completed ABC Quality Control Training in 2025.

PH

PC Holdings

Diploma, Education, Training and Development Practices

Completed a Diploma in Occupationally Directed Education, Training and Development Practices in 2012.

PC

PC Training and Business College

Diploma, Business Administration

Activities and societies: Top Academic Student; Ranked No. 1 in Faculty of Business Administration

Completed a Diploma in Business Administration in 2010, ranked as the top academic student in the Faculty of Business Administration.

AA

Academic Advance

Certificate, Clinical Research Ethics

2024 - 2024

Completed Ethics & Good Clinical Practice (GCP) training in 2024.

CA

Canvas

Certificate, Clinical Research Quality

2023 - 2023

Completed Clinical Research Quality Control training in 2023.

AA

Academic Advance

Certificate, Clinical Research Coordination

2022 - 2022

Completed Clinical Research Coordination training in 2022.

Tech stack

Software and tools used professionally

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