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:
- Ensure Quality Assurance and Quality Control activities are performed effectively across studies
Location:
- 7 Esselen Street, Hillbrow, Wits RHI Research Centre Clinical Research Site (CRS)
Key performance areas:
- Review and ensure that the study has all essential regulatory documentation through routine update as needed
- Assist with the review and revision of standard operating procedures per study specific needs as needed
- Assist Regulatory Compliance Officer with QA of regulatory files
- 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
- Perform duties per study Delegation of Authority Logs
- 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
Required minimum education and training:
- Diploma or Degree in a health-related field
Required minimum work experience:
- Minimum 2- years relevant work experience within a Clinical Research Environment in Quality Control and Quality Assurance
Desirable additional education, work experience and personal abilities:
- A Post-Graduate Degree in Quality Management would be an added advantage
- Understanding of the research language, detailed knowledge and understanding of the relevant studies and SOPs, knowledge of clinical research documentation. Computer literate with ability to create or work with relevant data sets
- Fluent in English, fluency in one of the other official SA languages particularly Zulu or Sesotho would be an added advantage
- Good written and verbal communication skills
- Strategic thinking and problem-solving skills
- Conscientious and precise delivery of work even when under pressure
- Effective self-management, resourcefulness and initiative to solve problems
- Excellent communication and presentation skills
Demands of the job:
- Local and international travel will, and overtime may be required.
- Ability to work over weekends
- Required to lift heavy duty files for storage in a fire-proof steel cabinet
- Highly pressurized environment may cause some stress
- Take ownership and accountability for tasks and demonstrates 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 ongoing training and development activities such as conferences, workshops etc.
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: 25 August 2025
- 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:
- Research Study Assistant
- Quality Assurance
- Quality Control
- GCP
- Post Graduate Degree in Quality Management
- Johannesburg
- Diploma
