A Quality Assurance Officer vacancy is available at our Client Wits Health Consortium’s Reproductive Health and HIV Institute (RHI) in Hillbrow -Johannesburg.
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.
Main purpose of the job:
- Ensure QA and QC activities performed effectively across studies. Where trends identified, coordinate relevant staff training. Keep track of data and regulatory requirements
Location:
- Ward 21 Clinical Research Site 22 Esselen street, Hillbrow, Johannesburg
Key performance areas
- Verify transcription and accuracy of data from source documentation to Case Report Forms (CRF)
- 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 reviews
- Coordinate staff training (and retraining) where required.
- Review and ensure that the study has all essential regulatory documentation through routine update as needed
- Assist with the review and revision of standard operating procedures per study specific needs as needed
- 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
- 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
- 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 for driving own career development by participating in ongoing training and development activities such as conferences, workshops etc.
Required minimum education and training
- Certification in Data Management or 3-year diploma or degree in a health-related field
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 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.
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 experienceas mentioned above, you may submit a detailed updated CV –Please Apply Online
- Please take note that the applicants who donotadhere to the above criteria will not be considered for the respective position.
- The closing date for all applications is30 November 2020.
- 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 fromdesignated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.
Please note that AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
AJ Personnel does not have any salary or other information regarding the position
Employer & Job Benefits:
- Medical Aid and Provident Fund