Medical Officer; Doctor – Evaluation of LLMs - FTC - Wits VIDA

Background

• The Vaccines and Infectious Diseases Analytics (VIDA) Research Unit of the University of the Witwatersrand, formerly RMPRU (Respiratory and Meningeal Pathogens Research Unit) has for over 20 years conducted numerous studies to assess the burden of and prevent vaccine-preventable diseases (VPD)
• Current studies and projects include infant rotavirus and BCG trials

To assist the VALID 2.0 study:

• Collection, abstraction and quality control of multimodal clinical data (written notes, imaging, etc.)
• Basic facilitation of expert panel discussions
• Quality control of data

• Primarily based at Chris Hani Baragwanath Academic Hospital

• Strategic review and management of observational studies i.e. devising systems and processes to ensure effective and efficient study conduct in liaison with programme and organisation management
• Collect, abstract and quality control clinical data as per the study requirements in accordance with Good Clinical Practice and Standard Operating Procedures

• Plan, implement and complete the study research activities in accordance with Good Clinical Practice and standard operating procedures
• Oversight of the study operations at different sites in collaboration with the Project Manager, ensuring the project is scoped, planned, budgeted and executed according to protocol guidelines and relevant policies and procedures with effective resource management and collaboration
• Collaborate with investigator/s and design projects in line with protocol requirements
• Project planning including timelines, budgets where applicable, deliverables, dependencies and resource planning
• Manage teams and resources required including cross-functional inputs and teams/staff to effectively drive objectives and efficiency
• Implement, document and track project deliverables and milestones including all administrative requirements
• Coordinate and conduct project-related training and skills assessments as well as provide site support in the case of multiple sites
• Organise and attend or lead meetings, presentations and calls as required
• Drive all regular internal and external report preparation and delivery
• Collaborate and liaise effectively with colleagues and other departments towards effective and efficient project planning and delivery
• Identify areas for improvement in process flow and project management and collaborate with research leads senior management to initiate and drive process improvements; take initiative and show ownership

• Assist with creating CRFs and quality assurance of study file source data, i.e. clinical source notes and CRFs
• Develop a research management plan in conjunction with PI and PM and oversee and ensure compliance
• Ensure ethics and consent processes are followed as per GCP guidelines
• Collaborate with investigator/s on participant recruitment and retention and contribute to community liaison strategies
• Develop and maintain project-specific SOPs
• Maintain the site file and review monthly in collaboration with the regulatory department
• Drive the quality assurance framework for the project and ensure research quality and processes are adequately monitored
• Perform monitoring and evaluation functions by ensuring that data is collected systematically on specified and agreed‑upon indicators
• Training/escalation for corrective action for site staff based on all applicable monitoring or quality findings
• Liaison with the data management to ensure high‑quality data and database management
• Complete and submit Ethics and Regulatory documents or reports
• Track protocol approvals, communications, certifications, translations, and all study administrative and compliance indicators
• Monitor and report critical events and protocol deviations

• Appropriately escalse all relevant issues to the required and respective stakeholders
• Support the development of long‑term health sciences research including strategic planning and driving action plans with indicators
• Pursue own research interests consistent with the overall research agenda of the organisation and…