Medical Officer

**Additional information**:

- _Wits VIDA Research Unit conducts cutting-edge scientific research_
- _The Unit aims to save lives across Africa in low and middle-income countries through translational research that informs local and global policy recommendations on infectious diseases and the use of next-generation and novel vaccines_
- _Their research is focused on clinical and molecular epidemiology of vaccine-preventable disease, clinical development and evaluation of vaccines, the study of the immunology of vaccines including in people living with HIV, and basic science research aimed at the discovery of potential vaccine epitopes_
- _The paediatric and neonatal surveillance research portfolio includes but is not limited to viral and bacterial surveillance in infants and young children admitted across various tertiary hospitals across the country_

**Main purpose of the job**:

- To provide medical leadership in support of clinical research activities, including overseeing relevant research streams, providing clinical insight and direction for all aspects of studies (including, for example, screening and enrolment of study participants, oversight of data and clinical research operations)

**Location**:

- **VIDA - Chris Hani Baragwanath Hospital, Soweto - Johannesburg**

**Key performance areas**:

- Clinical Research Direction_
- Strategic review and management of observational studies i.e., devising systems and processes to ensure effective and efficient study conduct in liaison with program and organization management
- Perform study-related procedures, blood draws, vaginal and rectal swabs nasopharyngeal aspirates/swabs on infants, young children, and adults including pregnant women, and other procedures as required
- Project Management_
- Plan, implement and complete the clinical research activities for the observational studies in accordance with Good Clinical Practice and Standard Operating Procedures
- Oversight of the PNS portfolio, ensuring projects are 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 who may work across projects 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
- or field-specific support in the case of multiple sites and/or fieldwork
- 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
- 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 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 unit and project-specific SOPs
- Maintain all site files and review monthly in collaboration with the regulatory department
- Create and drive quality assurance framework for projects and ensure research quality and processes are adequately internally 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, insurances, 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
- Act as first contact liaison with the Ethics Committee in respect of all projects within your domain and liaise with the research administration and unit regulatory team on required submissions and maintenance
- Ensure all administrative tasks are concluded effici