Job Description

Main purpose of the job:
To assist in a branch of the generative AI-focused Evaluation of LLMs study:
1.VALID (Validation of AI vs Local doctors In Diagnosis):

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

Location:

• VIDA - Chris Hani Baragwanath Hospital

Key performance areas:
1. Study Research Activities

• 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 (GCP) and Standard Operating Procedures (SOP)

2. Project Management

• 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

3. Quality Assurance and Regulatory Oversight

• 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 escalate all relevant issues to the required and respective stakeholders

4. Research and Academic Development

• 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 in conjunction with the research leadership team
• Advise on the implementation of large multi-site research and dynamically contribute to new, relevant research questions
• Design, write, and submit or contribute to new proposals
• Oversee adequate and accurate filing of all study-related files
• Prepare for study closure and archiving
• Conduct some data analyses and prepare tables as required
• In conjunction with Study Managers and respective P.I create and implement a sound Patient Retention Strategy (if required)
• Develop and implement required checklists e.g Inclusion and Exclusion Criteria, Randomisation Controls (where required)
• Ensure that donor compliance is met including procurement, timesheets and all sponsor/ donor reports
• Provide ad hoc support to department or functional team leads to ensure that project targets and goals are met
• Arrange site visits in conjunction with donors
• Compile and ensure review and submission of accurate, factual reports to the various stakeholders in line with relevant requirements
• Liaise with government departments and attend stakeholder meetings as required
• Operational finance records and stock management of the project
• Liaise with the maintenance and operations team to ensure the functionality of unit equipment and facilities
• Generate reports including but not limited to: Participant recruitment and retention rates; tracking follow-up reports; progress reports on compliance; data management oversight reports; study deliverables reports and any reports required by investigators

5. Customer service and Stakeholder Relations

• Build and maintain authentic, professional relationships and communicate effectively and efficiently with all internal and external stakeholders (suppliers, collaborators, researchers, donors, etc.)
• Train staff effectively; foster a practice of knowledge exchange and peer learning
• Manage internal and external stakeholder expectations and communicate appropriately with initiative and solutions
• Maintain a high standard of successful internal and external stakeholder relations (e.g. negotiations, building productive relationships)
• Escalate issues appropriately, ensuring adequate discretion and risk management, and demonstrate integrated problem-solving
• Effectively manage work processes, the team and relationships to maintain high levels of productivity

6. Staff Management

• Lead cross-functional teams to promote productivity within projects
• Work with management to empower and develop teams or individuals as skills needs or deficiencies are identified
• Foster an environment that promotes talent recognition, development as well as agency and individual leadership; promote harmony, teamwork and sharing of information
• Mentor, coach and facilitate personal and professional staff development wherever possible
• Ensure teams comply with policies, unit standards and administrative and internal communications requirements; promote company policies, strategies and values
• Manage staff effectively including accountability, performance, conduct, efficient working, processes and corrective action as required
• Demonstrative effective delegation and decision-making

7. Effective Self-Management/Performance Ownership

• Take ownership and accountability for tasks & activities and demonstrate effective self-management
• Actively and consistently maintain high standards of professionalism in all aspects of personal presentation and delivery
• Apply knowledge of the organisational systems, structures, policies and procedures to achieve results
• Follow through to ensure that productivity standards are consistently and accurately maintained and provide appropriate resolution for challenges
• Support and drive the organisation's core values
• Maintain a positive attitude and respond openly to feedback; manage your own disruptive emotions and stress
• Take ownership of driving own career development

Required minimum education and training:

• MBChB/MBBCh Degree; ability to coordinate study efforts in collaboration with the Project Manager and abstract clinical information from written notes Comfort with the Microsoft Office suite
• GCP Certification

Required minimum work experience:

• At least three years of neonatal and/or pediatric clinical experience
• Must have reporting and presentation skills as well as some staff management experience

Desirable additional education, work experience and personal abilities:

• Experience with research and project management will be an advantage
• Understanding of research environment, regulatory and ethics and Good Clinical Practice (GCP)
• Project management skills and usage of relevant tools
• Quality assurance experience
• Ability to liaise with external stakeholders at all levels, including students, academic collaborators and internal partners
• Strong networking and relationship-building ability
• Able to draft and review Standard Operating Procedures (SOP)
• Advanced computer literacy including basic data presentation and quality
• Conflict management and problem-solving ability
• Attention to detail is critical
• Ability to work extended hours
• Ability to work with multiple conflicting deadlines and maintain productivity and high standard of output
• Deadline orientated
• Ability to work within the contexts of international regulatory bodies
• Flexibility

Communications and Relationships:

• High level of written and verbal communication level at all levels of the organisation and with external stakeholders

Competencies Required: Baseline

• Reliability, integrity, accountability, diversity, self-awareness

Competencies Required: Category specific

• Analytical thinking, adaptability, initiative, flexibility, leading and developing others

TO APPLY:

• Only if you meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV
• Please Apply Online and complete your registration via our website to enable and protect you as a candidate, and to accept the new POPIA terms and conditions
• This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL
• However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market
• Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position
• Wits Health Consortium will only respond to shortlisted candidates
• Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful
• Closing date: 23 July 2025
• Note: No CV will be accepted after the closing date

Please note:

• WHC, in accordance with its Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto
• AJ Personnel is only responsible for advertising and the response handling on behalf of their client Wits Health Consortium
• AJ Personnel does not have any salary or other information regarding the position