Quality Assurance Officer

Full-time

VACANCY
Job title: Quality Assurance Officer
Type: Permanent ☒ Fixed Term ☐ Temporary ☐
Main purpose of the job:
Perform QA and QC activities across studies. Track Trends and implement
corrective action and future preventative measures. Ensure that quality of data
is of a high standard and ready for audit / inspection.
Location: Ward 21 CRS – 22 Esselen street, Hillbrow, Johannesburg
Closing date: 7 October 2021
Submit detailed CV to: Vacancy7@wrhi.ac.za
Advert reference number: PM072_2021
In accordance with our Employment Equity goals and plan, preference will be given to suitable applicants
from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments
thereto.
Our Organisation maintains a Mandatory COVID-19 requirement and as such only COVID-19 Vaccinated
incumbents will be considered for positions.

Key performance areas
Technical support – Quality Control
Verify transcription and accuracy of data from source documentation to Case Report Forms (CRF)
Perform QC1 , QC 2.
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 and EDC QC
reviews, as necessary.
Ensure completion of corrective action of internal and external QC reports.
Assist in completion of corrective action for monitoring visits.
Coordinate staff training (and retraining) where error trends are identified.
Update electronic database with Q.C findings and track resolution.
Technical support – regulatory
Review regulatory files and ensure that the study has all essential regulatory documentation through the
course of the study.
Assist with the review and revision of standard operating procedures
Technical Support – Quality Assurance
Support Regulatory/Data Manager 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
Technical support –external Monitoring
Ensure site is well prepared for external lab, clinical, social science and community monitoring reviews.
Assist sponsors/monitors before, during and after the review.

Assist regulatory compliance manager, project managers/team in completion of corrective action for external
monitoring reviews
Required minimum education and training
3-year diploma or degree in a health-related field with experience in Quality Assurance(QA) and Quality
Control (QC) of research studies/Clinical trials. A post graduate degree in Quality management would be an
added advantage.
Desirable additional education, work experience and personal abilities
Health related qualification with experience in QA/QC of research studies. 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 databases. 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. Excellent attention to detail. Knowledge of network studies
and DAIDS requirements would be an advantage.
Required minimum work experience
Minimum 1-2 years relevant work experience within a clinical research environment in Quality Control and
Quality Assurance.
Should you be interested in applying for this vacancy, please send an email to vacancy7@wrhi.ac.za. The
subject heading of the email must read PM072_2021 and the Job title of position applying for. Please include
the following documentation:
• A cover letter (maximum one page) that clearly states which vacancy you are applying for
• A detailed CV