Quality Assurance Officer (WITS RHI)

Main purpose of the job: To ensure QA and QC activities are performed effectively across studies Identify trends and coordinate relevant staff training 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 CRFs are corrected, initialled and dated by the authorized signatory Support the timely capturing 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 Ensure site is well prepared for external lab, clinical, social science, and data monitoring reviews Assist sponsors/monitors before, during and after the review Assist regulatory compliance officer, project managers/team in completion of corrective action for external monitoring reviews/audits and inspections Required minimum education and training: 3-year Diploma or Degree in a Health related field Required minimum work experience: Minimum 1-2 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 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: 10 July 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

Location: Hillbrow, ZA

Posted Date: 7/3/2025