Quality Assurance Officer x2: DPP/SAMURAI FTC/RHI

SUMMARY:
A Quality Assurance Officer x 2: DPP & SAMURAI Study - (Fixed Term Contract) vacancy is available at our Client, Wits Health Consortium's Reproductive Health and HIV Institute (RHI) in Hillbrow - Johannesburg.

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.

Main purpose of the job

• Ensure QA and QC activities performed effectively across studies
• Where trends identified, coordinate relevant staff training

Location

• 7 Esselen Street, Research Centre, Hillbrow

Key performance areas

• Review and ensure that the study has all essential regulatory documentation through routine updates as needed
• Assist with the review and revision of standard operating procedures per study-specific needs as needed
• Assist Regulatory Compliance Manager/Officer with QA of Regulatory files
• Verify transcription and accuracy of data from source documentation to Case Report Forms (CRF)
• Ensure errors on CRF’s are corrected, initialed and dated by the authorized signatory
• Support the timely transmission/data faxing/data entry of relevant Case Report Forms following QC activity (as needed)
• Ensure completion of corrective action of internal and QC reports/error trends identified during QC
• Assist in completion of corrective action for internal monitoring reviews
• Coordinate staff training (and retraining) where error trends are identified
• QC of Informed Consent Forms and other source documents to ensure accuracy and completeness
• Timeous reporting to project investigator/study coordinator or designee regarding QC trends and major issues
• Support periodic quality assurance activities as per the CQMP
• 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
• Ensure 100% QA of ICFs
• Ensure the site is well prepared for external lab, clinical, social science and data monitoring reviews
• Assist sponsors/monitor/auditor before, during and after the review
• Assist regulatory compliance manager, project managers/team in completion of corrective action for external monitoring reviews/audit and inspections
• 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 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

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 the ability to create or work with relevant data sets
• 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 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 02 February 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 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. 

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