Nikiwe Chauke

Experience

• 

  Dis-Chem Pharmacies

  Jun 2022 - Dec 2022

  Dispensery Support
• 

  MSD South Africa

  Jan 2023 - now

  As a Clinical Research Associate , I serve as the primary point of contact and site manager for allocated sites throughout all phases of clinical research studies. My key responsibilities include:- Building and maintaining strong relationships with sites to ensure continuity throughout the trial- Conducting site management and monitoring activities in compliance with ICH-GCP, sponsor SOPs, local laws and regulations, protocol, and associated documents- Performing remote and on-site monitoring to ensure data quality, subject safety, and well-being- Conducting site visits and documenting comprehensive visit reports in a timely manner- Managing regulatory documentation for study start-up, maintenance, and close-out- Communicating with investigators and site staff on protocol conduct, recruitment, retention, and site performance- Identifying and resolving site performance, quality, or compliance issues and escalating as needed- Maintaining accurate and up-to-date information in CTMS, eTMF, and other systems- Supporting audit and inspection activities as neededI also perform co-monitoring activities and ensure compliance with all relevant regulations and guidelines. My expertise includes site management, monitoring, and quality assurance, with a focus on ensuring the integrity and compliance of clinical research studies Show less Graduate Development Programme:Clinical Trials Coordination:- Managed documentation and systems for multiple clinical trials, ensuring accurate distribution and archiving of trial documents.- Coordinated setup and customization of study site files, updated clinical trial databases, and maintained clinical and non-clinical systems.Clinical Document Management:- Prepared, collated, and archived clinical documents and correspondence.- Collected forms and lists from investigators for site evaluation and validation.- Prepared submission packages for regulatory and ethics for new study submissions Communications:- Led the editorial and distribution of a quarterly departmental newsletter, communicating key activities to stakeholders.Skills:- Team Organization- Administrative Assistance- Critical Thinking Show less

  • Junior Clinical Research Associate

    Dec 2023 - now

  • Clinical Research Graduate

    Jan 2023 - Dec 2023