SUMMARY:
A Quality Assurance Officer vacancy is available at our Client, Wits Health Consortium’s Wits Reproductive Health and HIV Institute (Wits RHI) in Hillbrow, Johannesburg - Gauteng.

POSITION INFO:

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. This is done through pioneering, multi-disciplinary research; responsive technical support and innovation in health services; and evidence-based policy development and advocacy with national, regional, and global stakeholders.

The main purpose of the job 

• Perform QA and QC activities across studies
• Track Trends and implement corrective action and future preventative measures
• Ensure that the quality of data is of a high standard and ready for audit/inspection

Location

• Ward 21 CRS - 22 Esselen Street, Hillbrow, Johannesburg 

Key performance areas 

Technical support - Quality Control

• Verify transcription and accuracy of data from source documentation to Case Report Forms (CRF)
• Perform QC1 and QC 2
• Ensure errors on CRF’s are corrected, initialed, 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 the 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 the 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

TO APPLY

• Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV - Please Apply Online
• Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
• The closing date for all applications is 13 August 2021.
• 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.
• 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.

Please note that 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.

NB! This job is now closed. You can apply for other jobs by uploading your CV.