Job Description

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 efficiently

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 organization 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
• Identify and pursue new funding opportunities in line with the organizations interest and own research goals
• 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 and Randomization 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 stakeholders 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.)
• 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 in order to maintain high levels of productivity

Staff management

• Lead cross-functional teams to promote productivity within projects
• Train staff effectively; foster a practice of knowledge exchange and peer learning
• Work with management to empower and develop teams or individuals as skills needs or deficiencies are identified
• Foster an environment that promotes talent recognition, and 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 & 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 organizational 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 organizations core values
• Maintain a positive attitude and respond openly to feedback; manage own disruptive emotions and stress
• Take ownership of driving your 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 programs
• Post-graduate studies in Public Health or Epidemiology or relevant - desirable

Required minimum work experience:

• At least 3 years of Neonatal and/or Paediatric clinical experience
• Must have reporting and presentation skills as well as some staff management experience
• Attention to detail is critical

Professional body registration:

• HPCSA registration
• Medical Protection Society

Desirable additional education, work experience, and personal abilities:

• Experience with research and project management in a grant-funded research environment will be an advantage
• Understanding and experience in research environment, regulatory, ethics, and Good Clinical Practices; grants management administration; project management skills and usage of relevant tools; quality assurance expertise
• 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
• Advanced computer literacy including basic data presentation and quality
• Conflict management and problem-solving ability

TO APPLY:

• Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
• Please Apply Online.
• Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
• The closing date for all applications: 15 April 2024.
• Note AJ Personnel is fully POPI compliant.
• Note WHC, in accordance with their 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.

Please note:

• AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
• 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.
• AJ Personnel does not have any salary or other information regarding the position.

AJ Personnel