About the position
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
Main purpose of the job:
- To provide medical leadership in support of clinical research activities, including providing clinical insight and direction for all aspects of clinical research (including, for example, screening and enrolment of study participants, oversight of data and clinical research operations)
Location:
- Chris Hani Baragwanath Academic Hospital
More Info:
- Wits VIDA Research Unit conducts cutting-edge scientific research
- We aim to save lives across Africa and, 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
- Our 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 Klebsiella cohort study is a component of the Paediatric and Neonatal Surveillance Portfolio
- This comprehensive portfolio encompasses viral and bacterial surveillance in infants and young children who are admitted to various hospitals across the country
- The studies within this portfolio delve into the origins and transmission of infectious diseases among different populations
- Furthermore, they explore preventative and containment strategies to mitigate the spread of infectious diseases specifically in children
Key performance areas:
Clinical 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
- Perform study-related procedures, blood draws and nasopharyngeal aspirates/swabs on infants, young children and adults, including other procedures as required
- Perform study-related activities, including screening, consenting and enrolment of participants, including storing and delivering study samples to the local laboratory, collecting isolates from the NHLS laboratory, and conducting verbal interviews with legal representatives
- Abstraction and verification of infant and maternal source notes, including maintenance of enrolment and abstraction logs
Project Management
- Plan, implement and complete the clinical research activities in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOP)
- Oversight of the Klebs Cohort study at the Neonatal and Paediatric Units, 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
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 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
- Monitor and report critical events and protocol deviations
- Appropriately escalate all relevant issues to the required and respective stakeholders
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
- 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
- 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
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
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
Effective Self-Management and 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 effectively report and conduct basic data and quality analyses using Microsoft Office programmes
Professional Body Registration:
- HPCSA and Medical Protection Society Membership
Required minimum work experience:
- At least three years of Neonatal and/or Paediatric 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 and experience in a grant-funded research environment will be an advantage
- Post-graduate studies in Public Health or Epidemiology or relevant desirable
- Understanding of research environment, regulatory and ethics and Good Clinical Practice (GCP); Grants management administration experience; Project management skills and usage of relevant tools; Quality Assurance experience; Ability to liaise with external stakeholders at all levels including community healthcare workers, government, funders, community partners, 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-solvi
