Responsibilities:

Clinical and safety management:

• Perform clinical activities related to the trial including clinical assessments, specimen collection, laboratory results review, oversight of the safety of study participants, determination of clinical eligibility, and administration of study product
• Conduct clinical interviews and administer study questionnaires
• Follow up, assess, and manage Adverse events (AEs), including serious AEs
• Undertake after hours and weekend work as required
• Rotate across clinical research sites and provide back-up where and when required.

Clinical document management:

• Complete all required study-related documentation according to the study protocol, Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) requirements.
• Report AEs, EAEs, and SAEs, document AEs, EAEs, and SAEs and write reports as needed

Project Management

• Ensure successful implementation of paediatric-related studies
• Conduct regular quality control checks to ensure accuracy of clinical data collection and good quality data
• Write reports / narratives / detailed chart notes as required

Research outputs:

• Contribute to unit documents, technical reports, posters, presentations and peer-reviewed publications
• Assist with the conceptualization of new research ideas
• Work towards leading new research projects within the unit
• Apply for small grants to support new work or sub-studies

Stakeholder Management / Research Translation

Clinical Training / staff capacity development:

• Train new clinicians, nurses and capacitate the research team at site level and within the Unit

Core Requirements:

• MBChB with paediatrics specialization (College of Medicine of South Africa)
• HPCSA registration as a specialist paediatrician
• Clinical assessment and management skills of:
• Common Childhood Illnesses
• Paediatric HIV prevention,
• Paediatric HIV
• Computer Literate
• Driver’s license (08)

Advantageous:

• MMed Paediatrics
• Diploma in HIV management (College of Medicine of South Africa)
• MPS (or equivalent) registration (NB: MPS registration must be active before starting the position).
• Recent APLS / or PALS or equivalent
• 1-2 years’ experience working in paediatric HIV
• 1-2 years’ experience managing paediatric HIV research studies
• SOP development
• Supervision of a team
• Experience in a clinical trial
• Knowledge of electronic and paper-based systems for data capture (REDCap, (Mobile/Online Application) or another system)
• Fluency in spoken and written, English and IsiZulu/ Northern Sotho / Sepedi / Setswana