Quality Assurance Officer

**Main purpose of the job**:

- Ensure QA and QC activities performed effectively across studies
- Where trends are identified, coordinate relevant staff training

**Location**:

- **Wits RHI - Research Centre, 7 Esselen Street, Hillbrow, Johannesburg**:

- **On the 3rd and 4th Floor**

**Key performance areas**:

- Review and ensure that the study has all essential regulatory documentation through routine updates 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, initialed, 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 the 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 the site management team
- Assist in the completion of corrective action for internal monitoring reviews
- Coordinate staff training (and retraining) where error trends are identified
- Ensure 100% QA of ICFs
- Ensure the 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 of 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, understanding of the relevant studies and SOPs, knowledge of clinical research documentation
- Computer literate with the 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

**TO APPLY**:

- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- _AJ Personnel is fully POPIA Compliant._
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.

**Please note**:

- **Our Client, WHC - RHI, maintains mandatory Covid-19 requirements, and as such only Covid-19 vaccinated incumbents will be considered for positions.**:

- 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 the advertisement on behalf of their client Wits Health Consortium.
- AJ Personnel does not have any salary or other information regarding the position.