Tumelo Kgoe

Clinical Research Associate with 4+ years of clinical research experience and independent site monitoring experience in oncology, currently working as an Analytical Monitor supporting clinical trial oversight through centralized data review, risk identification, and cross-functional collaboration. Experienced across study start-up, initiation, ongoing monitoring, and close-out, with hands-on responsibility for source data review/verification, investigational product accountability, essential document review, protocol and safety training, issue resolution, and monitoring report writing. Strong scientific foundation with an MSc in Pharmaceutical Science, BSc Honours in Biochemistry, and BSc in Physical and Chemical Sciences.

Working knowledge of ICH-GCP, clinical trial processes, regulatory compliance, and data interpretation.

Analytical Monitor / Central Review Lead at ICON Plc | Client-dedicated to Johnson & Johnson (2026-04 – Present)

• Conduct centralized analytical monitoring and targeted site- and subject-level data reviews to identify emerging trends, data quality concerns and potential clinical trial risks.
• Review data across clinical trial systems, dashboards and reporting tools to generate actionable insights and support proactive trial oversight.
• Partner with Site Managers, Central Monitoring and cross-functional stakeholders to support site prioritisation, risk management and timely issue resolution.
• Communicate findings clearly, follow escalation pathways where appropriate, and document monitoring activities in accordance with SOPs, regulatory requirements and quality standards.
• Apply clinical research knowledge, data interpretation and risk-based thinking to support patient-centric oversight across assigned studies.

Clinical Research Associate at ICON Plc | Providing services to MSD (2022-01 – 2026-03)

• Conducted independent on-site clinical monitoring activities across oncology studies, including source data review/verification, query follow-up and essential document review.
• Supported clinical trial sites through validation, initiation, ongoing monitoring and close-out activities, ensuring compliance with protocol requirements, ICH-GCP and applicable regulations.
• Managed investigational product accountability, including review of dispensation and return/destruction records, batch numbers and reconciliation activities.
• Delivered site training on protocol amendments, cohort schedules, important protocol deviations, serious adverse event reporting timelines and updated informed consent requirements.
• Prepared monitoring reports across study phases and communicated site findings, action items and clinical issues to study teams.
• Worked closely with investigators, site staff and cross-functional clinical team members to facilitate timely resolution of trial and operational issues.
• Maintained strong sponsor-site relationships while balancing quality, timelines, patient safety and protocol compliance.

Laboratory Analyst at Research Institute for Industrial Pharmacy / Centre for Quality Assurance Medicines (RIIP/CENQAM) (2020-10 – 2020-12)

• Performed LC-MS analysis of pharmaceutical products and prepared samples in accordance with laboratory procedures.
• Reviewed standard operating procedures and supported analytical testing activities.
• Performed daily calibration of analytical and microbalances and pH meters, and conducted water quality testing.
• Worked in compliance with GMP and ISO 17025:2017 quality requirements.

Laboratory Analyst at Research Institute for Industrial Pharmacy / Centre for Quality Assurance Medicines (RIIP/CENQAM) (2021-10 – 2021-12)

• Performed LC-MS analysis of pharmaceutical products and prepared samples in accordance with laboratory procedures.
• Reviewed standard operating procedures and supported analytical testing activities.
• Performed daily calibration of analytical and microbalances and pH meters, and conducted water quality testing.
• Worked in compliance with GMP and ISO 17025:2017 quality requirements.

Master of Science in Pharmaceutical Sciences – North-West University (2018-01 – 2019-12)

Bachelor of Science Honours in Biochemistry – North-West University (2017-01 – 2017-11)

Bachelor of Science in Physical and Chemical Sciences – North-West University (2013-01 – 2016-12)

Postgraduate Diploma in Medical Toxicology – Stellenbosch University