CLINICAL RESEARCH OFFICER
South African Tuberculosis Vaccine Initiative
Institute of Infectious Disease and Molecular Medicine
A. THE CONTEXT
SATVI is primarily engaged in the development of novel vaccines against tuberculosis through conduct of clinical
trials. The initiative also includes epidemiological, diagnostic, and immunological tuberculosis studies that will define
the clinical, microbiological, and immunological end-points for future Phase III tuberculosis vaccine trials. The studies
take place at the SATVI research site in Worcester, where SATVI has built up an established infrastructure for clinical
and immunological research, with over 100 research staff, and including a dedicated research ward, clinics, and a
laboratory.
The Clinical Research Officer will function as Investigator in designated SATVI studies under supervision of the PI;
provide clinical and safety oversight of ongoing studies; and conduct independent research leading to academic
outputs, as PI, based primarily at the Worcester SATVI Project Office.
B. THE POST
The Clinical Research Officer will function to maintain the integrity of the goals of all activities related to current
research projects as Investigator; and is directly responsible for study-related medical decision-making; participant
safety and safety reporting; operational decision-making where related to clinical issues; and the integrity, analysis,
presentation, and reporting of the study data. The Clinical Research Officer will act as designated back-up for the PI
for specified studies and provide input to the Study Co-ordinator on clinical issues. The Clinical Research Officer is
also responsible for development of self-initiated grant proposals to secure ongoing funding for future projects as PI,
will conduct independent research projects leading to academic outputs, and effect appropriate leadership in terms of
the longer-term strategic goals and objectives of SATVI.
C. JOB DESCRIPTION
JOB TITLE:
Clinical Research Officer
AREA:
South African Tuberculosis Vaccine Initiative, IIDMM
REPORTS TO:
PI
JOB PURPOSE:
The Clinical Research Officer will function to maintain the integrity of the goals of all activities related to current
research projects and is directly responsible for study-related medical decision-making; participant safety and safety
reporting; operational decision-making where related to clinical issues; and the integrity, analysis, presentation, and
reporting of the study data. The Clinical Research Officer will act as designated back-up for the PI for specific studies
and provide input to the Study Co-ordinator on clinical issues. The Clinical Research Officer is also responsible for
development of self-initiated grant proposals to secure ongoing funding for future projects as PI, will conduct
independent research projects leading to academic outputs, and effect appropriate leadership in terms of the longerterm strategic goals and objectives of SATVI.
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KEY PERFORMANCE AREAS:
i.
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Research
Function as Investigator for ongoing SATVI studies
Pursue post-graduate studies in the field of infectious disease and tuberculosis
Develop self-initiated grant proposals for future studies as PI
Conduct independent research projects
Publish and present research relevant to SATVI – expectation is that of
1 peer- reviewed publication in an international journal within 2 years
ii.
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Clinical Oversight
Be responsible for the day to day clinical management of participants enrolled in SATVI studies and clinical trials,
including safety monitoring and reporting, and all aspects of protocol compliance and reporting related to clinical
management of participants.
iii.
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Teaching & Learning
Supervision of students at the Worcester Site
Teaching during SATVI, IIDMM, and UCT workshops and courses
Mentorship of study staff in protocol-specific and generic clinical research
training
iv.
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Social responsiveness
Provide technical advice to regional health authorities with regard to TB, HIV
and other infectious diseases
Continuing medical education through participation in regular updates directed to
service providers at local, provincial and national level.
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v.
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Leadership, Management and Administration
Function as Investigator and provide support and back-up to the PI for
designated SATVI studies
Attend and participate in SATVI Management Meetings,
Provide and present updated relevant information at meetings
Contribute to strategic planning goal setting, and effect appropriate leadership in
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terms of the longer-term strategic goals and objectives of SATVI
Communication and liaison between SATVI project staff and sponsors, regional
health services, and community advisory board
Coordination of SATVI efforts to locate, apply for and secure supplementary
funding to support extended and additional studies
Characteristics of the incumbent
Desirable personal attributes and competencies:
 The ability to work in a team, foster co-operation between team members, build team spirit, and manage
people and co-ordinate their involvement in projects.
 The ability to be innovative, to look for creative solutions to difficult problems, to seek and propose new
opportunities to enhance effectiveness
 The ability to effect appropriate leadership in the attainment of goals and objectives, express opinions in a
constructive and assertive way, sharing information and encouraging feedback.
 The ability to think analytically and independently and aggressively tackle new challenges, breaking down
complex tasks into manageable parts in a systematic way.
Qualification
 Medical degree (MBChB or equivalent)
 Registration with HPCSA as a medical practitioner
 Additional postgraduate qualification(s) in one or more of the following would be advantageous:
o Medicine, Paediatrics, or Public Health.
o Infectious Diseases
o Epidemiology and / or Biostatistics
o Management
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Skills and Abilities
 Skills and experience in teaching
 Experience in group facilitation
 Skills and experience in research methods
 Excellent communication and writing skills
 Sound administration skills
 Computer Literacy and basic data management skills
 Basic biostatistics knowledge and skills
 Business acumen and academic / business writing skills
 Leadership skills
 Good interpersonal skills
 Management skills
 Sound presentation skills
Experience
 At least two years post-internship experience in working in the health or research sector
 The following would be advantageous:
o Experience in infectious disease clinical research/clinical trials and specifically clinical TB research
o Experience in vaccine clinical research/vaccine trials and specifically clinical TB vaccine research/TB
vaccine trials
o Experience and working knowledge of current enabling legislation as related to health and research
o Experience and working knowledge of Good Clinical Practice and the Protection of Human Participants in
Research
o Experience in Project Management
o Some experience in financial management
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