Quality Assurance Officer (Wits RHI)

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:

• Verify transcription and accuracy of data from source documentation to Case Report Forms (CRF)
• Perform QC1, QC 2, QC/QA
• Ensure errors on CRFs are corrected, initialed, and dated by the authorized signatory
• Support the timely submission 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 the completion of corrective action for monitoring visits
• Coordinate staff training (and retraining) where error trends are identified
• Update electronic database with QC findings and track resolution
• Review regulatory files and ensure that the study has all essential regulatory documentation throughout the course of the study
• Assist with the review and revision of standard operating procedures
• 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 the completion of corrective action for internal and external monitoring reviews
• Ensure the site is well prepared for any internal and external review
• Assist sponsors/monitors before, during, and after the review
• Assist regulatory compliance manager, and project managers/team in the completion of corrective action for external monitoring reviews
• 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, workshops, etc.

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:

• Post graduate Degree preferably at the Master's level is an added advantage
• Understanding of clinical trials, knowledge of clinical research documentation
• Computer literate with the ability to create or work with databases
• 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
• Knowledge of network studies and DAIDS requirements would be an 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: 06 December 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 - 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.