About the position
Background:
- The Wits Reproductive Health and HIV Institute (Wits RHI) is a renowned African-led research institute that seeks solutions to Africa’s health challenges
- It is located within the University of the Witwatersrand and addresses some of the greatest public health concerns affecting our region, including HIV and its related problems, sexual and reproductive health, and vaccinology
Main purpose of the job:
- To perform day to day of research related activities including but not limited to administration, laboratory activities, data collection, quality control, quality assurance, community recruitment and retention activities and ensuring compliance with regulatory and good clinical practice requirements within Research Centre studies at Wits RHI
Location:
- 7 Esselen Street, Hillbrow, Wits RHI Research Centre Clinical Research Site (CRS)
Key performance areas:
- Assist Medical Technician or Medical Technologist with stock control and monitoring for all studies
- Ensure timeous and logical filling of shipment documents, Lab meeting minutes, and any other lab documents
- Capture, store, and ship samples on LDMS for study related protocols
- Assist Regulatory Officers/Managers, Sponsors / Monitors before, during and after monitoring visits
- Support Reg Officer/Managers to maintain regulatory files and filing systems
- Document regulatory team meetings as and when required
- Ensure staff are compliant to timely GCP training and renewals through active review of trackers and bookings as requires
- Review and support the Regulatory Officer/Manager and ensure that the study has all essential regulatory documentation filed and tracked on excel trackers
- Updating tracking logs for all submissions, approvals
- Promote studies and recruit participants by conducting presentations, radio talks and distributing brochures at the community
- Address potential participants in accordance with recruitment targets and participant recruitment standard operating procedures (SOP)
- Inform willing participants that participation in the study is voluntary
- Conduct screening interviews to consenting participant to determine eligibility into study
- Schedule appointment with eligible participants to attend further screening at Wits RHI study clinic
- Record screened participants in screening register
- Administer study questionnaires
- Contact participants prior to their scheduled visits to remind them of their visits
- Visit home or contact participants telephonically to reschedule visits
- Prepare list of home visits according to priority and living area
- Address relevant concerns and misconceptions about the study
- Receive queries from participants and address or refer queries accordingly
- Verify transcription and accuracy of data from source documentation to Case Report Forms (CRF)
- Ensure errors on CRF’s are corrected, initialled and dated by the authorized signatory
- Support the timely transmission/data faxing of all Case Report Forms following QC activity
- Ensure completion of corrective action of internal QC reports/error trends identified during QC
- Assist in completion of corrective action for internal monitoring reviews
- Coordinate staff training (and retraining) where error trends are identified
- QC of all ICFs and other source documents to ensure accuracy and completeness
- Timeous reporting to study PI and study coordinator Regulatory Compliance Officer regarding QC and major issues such as protocol deviations
- Support Regulatory Compliance Officer with periodic quality assurance activities
- Assess staff awareness and compliance to Good Clinical Practice (GCP), Protocol requirements, Standard Operating Procedures (SOPs) and Regulatory Essential Documents per sponsor requirements
- Determine through critical review the accuracy of research records
- Compile QA/QC report/s on findings for site management team
- Assist in completion of corrective action for internal monitoring reviews
- Coordinate staff training (and retraining) where error trends are identified
- Ensure 100% QA of ICFs
- Obtain informed consent forms from study participants
- Ensure quality data capturing
- Ensure that ICF and source documents are completed and signed correctly
- Ensure that consent forms are accurately completed and signed by all parties
- File all participant forms according to the study requirements (alphabetic/numeric order) and ensure all forms are submitted to the relevant data capturers daily
- Follow GCP guidelines when completing participant visit forms
- Complete relevant project administration as and when required
- Document team meetings as and when required
- Compile weekly reports on activities, progress etc
- Conduct duties assigned per Delegation of authorities’ log
- Assist other cadres of staff when required and feasible
- Comply with Good Clinical Practice (GCP), protocol requirements and Standard Operating Procedures (SOP’S) in all lab duties, processes / activities
- Effectively communicate / report all quality challenges to the relevant manager / staff
- Verify accuracy of data in source documentation and accuracy of transcription/translation from source data
- Ensure timeous and accurate completion of corrective action of internal and external QC reports and monitoring reviews
- Transcribe audio files of focus group discussion and in-depth interviews in accordance with study specific templates
- Translate local language audio into English using one step method
- Review/quality control completed transcripts naming conventions
- Obtain informed consent from study participants
- Attend relevant external and internal meetings
- Take ownership and accountability for tasks and demonstrate effective self-management
- Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
- Maintain a positive attitude and respond openly to feedback
- Take ownership for driving own career development by participating in on-going training and development activities such as workshops, forums, conferences etc
- Apply knowledge of the organisational systems, structures, policies and procedures to achieve results
- Provide appropriate resolution for tasks or deadlines not met
- Support and drive the organisation’s core values
- Take ownership for driving own career development
Required minimum education and training:
- Degree in a Health-related field
Required minimum work experience:
- Minimum 1 year working experience within a clinical research environment
Desirable additional education, work experience and personal abilities:
- Confidentiality, tact and discretion must be maintained at all times
- Ability to manage self and prioritize own workload
- Self-motivated, able to work independently and as part of a multidisciplinary team
- Ability to work under pressure and meet deadlines
- Ordered and systematic with strict compliance to protocols
- Good administration skills
- Empathetic with good communication and interpersonal skills
- Must be able to work in the community with people who are vulnerable and patients who are HIV positive or negative and emotional due to the effects of the HIV disease
- Computer literate with ability to create or work with databases/excel logs and proficient in Microsoft Office
- Fluent in English and Zulu (advantageous)
- Excellent written and verbal skills
TO APPLY:
- Only if you meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV
- Please Apply Online and complete your registration via our website to enable and protect you as a candidate, and to accept the new POPIA terms and conditions
- This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL
- However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position
- 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
- Closing date: 03 February 2026
- Note: No CV will be accepted after the closing date
Please note:
- WHC, in accordance with its 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
- AJ Personnel is only responsible for advertising and the response handling on behalf of their client Wits Health Consortium
- AJ Personnel does not have any salary or other information regarding the position
Desired Skills:
- Administration
- Quality Control
- GCP
- Intern
- Research
- Hillbrow
- Degree
