Quality Assurance Administrator (Contract) Wits Ezintsha

Main purpose of the job:

• Ensure QA and QC activities are performed effectively, where trends are identified, and coordinate relevant staff training
• Maintain Regulatory Documents and assist with periodic review and revision of SOPs
• Oversee Electronic Data Capturing (EDC) process including query resolution

Location:

• Ezintsha – Parktown office - Johannesburg

Key performance areas:

• Assist with the review and revision of standard operating procedures per study-specific nee Verify accuracy of data from source documentation to EDC system
• Ensure errors on source documents are corrected, initialed, and dated by the authorized signatory
• Support the timely capturing of all Electronic Case Report Forms following QC activity
• Ensure completion of corrective action of internal and external QC reports
• Assist in the completion of corrective action for internal monitoring reviews
• Monitors source queries and data entry
• Assess staff awareness and compliance to Good Clinical Practice (GCP), Protocol requirements, Standard Operating Procedures (SOPs), and Regulatory Essential Documents per sponsor requirements, specifically Electronic Data Capture (EDC) guidelines
• Determine through critical review the accuracy of research records
• Compile QA/QC report/s on findings for QAO
• Coordinate staff training (and retraining) where error trends are identified
• Resolve all queries raised by external monitors
• Oversee data entry
• 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 of driving your own career development by participating in ongoing training and development activities such as conferences

Required minimum education and training:

• 3-years 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 databases
• Fluent in English, fluency in one of the other official SA languages particularly Zulu or Sesotho would be an added advantage

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 and complete your registration on Ditto Hire (our application tracking system) to enable and protect you as a candidate 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.
• 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.
• The closing date for all applications: 22 June 2022.
• 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.

Please note:

• Our Client, WHC - Ezintsha, 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.