Current Openings at Stellenbosch University

Duties        

• Providing strategic legal advice and high-level legal oversight;
• Analysing the University and higher education landscape to anticipate and identify legal risks, ensure compliance, and advise the Rectorate;
• Providing expert legal input into the development of policies and procedures related to the management of legal risk within the University;
• Serving as a sounding board for complex legal matters escalated by heads within various divisions;
• Oversight regarding collaboration on specific legal matters, where required;
• Engaging with government agencies and relevant authorities regarding legal and regulatory matters impacting the University;
• Representing the University at mediations, arbitrations, litigation and administrative boards or tribunals, in conjunction with external legal practitioners, where appropriate. 

Job Requirements    

• LLB degree;
• Admitted as an attorney or advocate;
• At least twenty years' experience of which at least five years have been in senior legal or managerial positions;
• Experience in working in highly regulated environments, negotiating complex agreements, managing litigation, and assessing legal risk;
• In-depth understanding of the South African legal system and knowledge of the legislative framework governing higher education;
• The ability to exercise sound judgment;
• Demonstrated leadership and communication skills, with the ability to build consensus and navigate complex situations;
• Experience in managing contentious situations comfortably with diplomacy, tact, and patience;
• Managerial skills, including the ability to direct, supervise, coordinate, and review the activities of direct reports, teams or individuals.

Recommendation    

• Extensive experience in higher education institutions or in close collaboration with higher education institutions. 

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Duties

• Strengthening the academic programmes offered by the DDRS with a specific focus on developing a postgraduate diploma (PGDip) in Assistive Technology; 
• Using innovative methods to undertake teaching, learning and assessment within academic programmes of the DDRS and renewed MBChB curriculum; 
• Coordinating relevant evaluation and research activities to inform the continuous improvement of the teaching and learning initiatives; 
• Leading and coordinating disability and rehabilitation research within the DDRS¿s strategic research focus areas; 
• Actively publishing research findings in peer-reviewed accredited journals, with a minimum h-index of 6; Providing research supervision and mentorship to master's and doctoral students at a senior level; Organising CPD activities, short courses and seminars about relevant topics;  
• Fostering collaboration and engagements with units in the Faculty, University, and other educational and research institutions; 
• Securing funding to support research, training, or service. 

Job Requirements    

• Master's in health sciences or a disability and rehabilitation related field; 
• Experience as a health and rehabilitation practitioner working with people with disabilities;
• Experience in developing a curriculum in disability and rehabilitation studies; 
• Experience in teaching and coordination of postgraduate programmes at senior level; 
• Expertise and experience in mentoring and facilitating learning and assessment in postgraduate disability and rehabilitation studies at a senior level; 
• Expertise in both quantitative and qualitative research methods;
• Evidence of successful research supervision of master's and doctoral students at senior level; 
• Demonstrable success in obtaining external research funding to support own research; 
• A publication record in disability and rehabilitation studies with an h-index of 6 or more;
• Evidence of established regional and international collaborations within the area of Assistive Technology; Project management, coordination, and networking skills; 
• The ability to work independently and in a team. 

Recommendation        

• PhD in health sciences or a disability and rehabilitation related field;
• Track record of research on teaching and learning in disability and rehabilitation studies at senior level; Proven record of scholarly and scientific achievement and the ability to maintain it;  
• An interdisciplinary approach to problem-solving; 
• Excellent communication and presentation skills. 

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Duties

Administrative

• Serving as a liaison to Sponsor/CRO/Regulatory Authorities/Investigators;
• Participating in team meetings and conference calls with the Principal Investigator (PI) and sub-investigators for the different protocols, and taking and circulating minutes;
• Setting up unit and study team meetings as required;
• Providing support to the clinical team, thereby ensuring continuity of service and problem resolution;
• Ensuring that study specific and general training is done for all (new) staff and for amendments;
• Ensuring that all study material is correctly archived after study close-out visits;
• Retaining documentation of vendor qualifications;
• Effective operations and delivery of site activation deliverables within the assigned study. 

Facility oversight

• Identifying and ordering all supplies needed for the studies, and ensuring that they are available for the execution of the study in collaboration with relevant site administrative personnel;
• Overseeing that all equipment is calibrated at least once a year, or as per product / sponsor guidelines;
• Overseeing maintenance of all clinical and laboratory equipment in collaboration with the laboratory group;
• Overseeing monthly check of emergency trolley and after use in the event of an emergency;
• Ensuring that the necessary temperature monitoring is in place for all relevant items, including but not limited to IP and laboratory kits.

Regulatory

• Engaging with internal and external stakeholders as appropriate, including, but not limited to, SAHPRA, USHREC, NHREC, DOH, CCT, TBH and any other regulatory authority as determined by the study/sponsor;
• Maintaining up-to-date knowledge of the relevant ethics committee, SAHPRA and external stakeholders regulations;
• Compiling and submitting submission documents and reports to the ethics committee, SAHPRA and external stakeholders according to their guidelines, SOPs and timelines;
• Submitting AEs, EAEs, SAEs, safety reports, protocol deviations and CAPAs, etc., as per the ethics committee and SAHPRA guidelines, SOPs and timelines.

Quality control and quality assurance

• Ensuring that knowledge of quality control and quality assurance processes is compliant with trial and site requirements (SOPs);
• Implementing, maintaining and updating current quality assurance processes;
• Assessing status of quality at site.

Clinical operations / study start-up / activation

• Acquiring and maintaining in-depth knowledge of the protocol and its amendments, and guiding documents such as the Manual of Operations (MOP), Study Specific Procedures Manual (SSP) and site specific standard operating procedures;
• Being up to date with all aspects of the trial - enrolment, retention, major deviations, etc.;
• Organising training sessions for study staff. Developing training slides or practical training sessions;
• Developing and maintaining ISF throughout the trial, from study start-up until study close-out;
• Developing and maintaining source documentation that satisfy the information needed for completing the CRFs;
• Developing CRF templates based on the requirements of the protocol (if indicated);
• Pro-actively identifying risk factors / challenges for studies and research sites. Developing and implementing contingency plans with the multidisciplinary team;
• Ensuring that general and study-specific processes comply with the protocol, the MOP and with standard operating procedures (SOPs). Adhering to GCP and regulatory requirements (local and international);
• Completing quality control and quality assurance procedures;
• Setting recruitment goals and timelines in collaboration with the PI and site personnel, and developing recruitment plans and strategies;
• Preparing for monitoring visits and serving as contact person for monitors during the visit;
• Managing relevant members of the research team on-site: training, delegating and coordinating staff;
• Liaising closely with clinical, regulatory, admin, laboratory, pharmacy, data and other relevant teams.

DAIDS / other networks / grant funded studies

• Informing the clinical research site coordinator of any changes in the site operations;
• Preparing required documents for trial network submission in a timely manner;
• Timely review and submission of CSM findings to the regulatory team.    

Finances

• Assisting with monthly billing verification of visits completed at site, and providing feedback to the PI.

Job Requirements    

• A tertiary qualification in nursing, or a B-degree in medical science or a related field;
• Active registration with SANC/HPCSA (if applicable);
• At least three years' experience working with IMPAACT, ACTG or TBTC network, or other clinical TB therapeutic trials involving investigational products;
• At least two years' experience working as a study coordinator on TB, or TB and HIV, or other infectious disease related randomised clinical trials in children and/or adults involving an investigational product;
• Actively coordinating at least two clinical trials (one being a randomised clinical trial) as a study coordinator;
• Experience in quality control and quality assurance processes;
• In-depth knowledge of compiling documents and making submissions to SAHPRA, the ethics committee, the Departement of Health, the City of Cape Town, and other health authorities;
• The ability to work accurately according to protocol and related documents, SOPs and regulatory requirements;
• The ability to work independently, or in a team environment as a member of an interdisciplinary team;
• Sound interpersonal skills;
• Strong organisation and prioritisation skills;
• Excellent written and verbal communication skills in English;
• The skills to solve problems independently and effectively;
• A goal-oriented disposition;
• Excellent computer skills in MS Word, PowerPoint, Excel and Teams;
• A valid driver's licence and own transport.

Recommendation        

• Knowledge of national and international regulatory requirements;
• Experience of performing quality assurance and regulatory functions for clinical trials, preferably on infectious diseases (TB and HIV in particular);
• Experience of community-based clinical research on TB, or on TB and HIV;
• Experience of working with industry sponsored pharmaceutical trials will be advantageous;
• Additional language skills in Afrikaans, isiXhosa or isiZulu (or more than one of these languages).

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Duties    

• Supporting the Study Doctor in leading and managing the day-to-day logistics of the study, which will include booking patient visits, organising vehicle hires, and arranging imaging bookings;
• Collecting longitudinal qualitative data from child/caregiver participants in the iThemba study;
• Carrying out research activities in collaboration with other research team members, including recruitment and consent, data collection, etc.;
• Carrying out neurodevelopmental and sociobehavioural assessments on children within the study;
• Liaising with research participants and stakeholders in research communities at an operational level;
• Maintaining data safety, integrity, and anonymity;
• Reporting team statistics at weekly wider DTTC paediatric meetings;
• Disseminating results, general study related information, and in relevant mobilisation, education, and promotion of the study to community members;
• Implementing data analyses with the support of the study investigators;
• Representing the research study at research stakeholder meetings (such as government partners);
• Drafting summary reports of analyses and research progress for in-team discussion and dissemination to funders, ethics, and other partners;
• Representing the interests of the research in community forums with integrity and transparency;
• Building a rapport with study participants and members of study communities to facilitate study implementation;
• Continuously developing research and administrative capacity through appropriate reading, attending relevant training, and in-service learning from management;
• Any other responsibility required by line management.

Job Requirements    

• A master's degree in a social sciences discipline (such as psychology, sociology, economics, anthropology, epidemiology, or public health);
• Two years' postgraduate work experience in the field of research;
• A firm grounding in a range of research methods;
• The ability to work independently as well as within a project-team environment;
• Sound interpersonal skills and the ability to function in an interdisciplinary team;
• A goal-oriented disposition and the skills to solve problems independently and effectively;
• Computer literacy in MS Word, PowerPoint and Excel;
• Excellent, demonstrable written and verbal communication skills;
• Authorship of a peer-reviewed publication;
• The ability to fluently speak, read and write English;
• Experience of doing research in South Africa, or knowledge of HIV/TB social science research and the civil-society landscape in the Western Cape;
• A keen interest in pursuing a PhD related to the project.

Recommendation        

• Experience of presenting research outputs academically for conferences, academic meetings, etc.;
• Fluent in another official South African language (such as isiXhosa and / or Afrikaans);
• A valid driver's license and own transport;
• First authorship of a peer-reviewed publication.