Quality Assurance Manager (1 Year FTC) RHI
PNet (Pty) Ltd
JHB - Central
6d ago

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

  • To coordinate the quality assurance (QA), quality control (QC), data processing and data management activities of research projects such as developing standard operating procedures, overseeing / coordinating QA / QC activities, data capturing and providing analysis output and training
  • Key performance areas

  • Coordinate QC activities of the QA / QC officers
  • Assist with QC when required
  • 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 relevant Case Report Forms following QC activity (as needed)
  • QC of Informed Consent Forms and other source documents to ensure accuracy and completeness
  • 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
  • Timeous reporting to Investigator of Record, Principal Investigator, Programme Manager or Study Coordinator as applicable regarding QC trends and major issues
  • Conduct 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 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
  • Assist Regulatory Compliance Officer with QA of Regulatory files
  • 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
  • Ensure 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 staff with completion of corrective action for external monitoring reviews / audit and inspections
  • Provide technical input into research tool and database design, analysis and interpretation of data
  • Develop and implement data management work plans
  • Develop, implement and maintain all data related SOPs
  • Quality assures all data in accordance with ethical and GCP requirements and SOPs
  • Monitor and evaluate progress of data management for respective projects
  • Compile monthly / quarterly / annual progress reports as required
  • Oversee the maintenance of participant files and archiving
  • Participate in and represent data management team at meetings as required
  • Delegate and oversee data capturing and assist as needed
  • Raise and resolve data queries with clinic staff
  • Provide support to relevant project staff and support them in the use of statistical software
  • Import and export data between data management software programmes
  • Process and produce accurate data reports within required timeframes
  • Attend to all staffing requirements and administration
  • Supervise and manage the duties of subordinates to ensure optimal staff utilisation and maintenance of sound labour relations
  • Perform and facilitate performance development and assessments
  • Identify substandard performance by team members and take necessary corrective action
  • Coach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organisation
  • Promote harmony, teamwork and sharing of information
  • Required minimum education and training

  • 3 year Diploma or Degree in a Health Related Field / Diploma in Information Technology or Statistics (or equivalent)
  • Certification in data analysis programmes (STATA, SAS, SQL and Access)
  • Minimum 2 years’ experience in quality control, quality assurance and data management, analysis and reporting
  • Desirable additional education, work experience and personal abilities

  • A post graduate degree in Quality Management would be an 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 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
  • Certification in good clinical practice will 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
  • 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 17 October 2018.
  • 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.

    SCAM ALERT - PLEASE BE AWARE! NOT AJ PERSONNEL OR ANY REPUTABLE AGENCY NOR ANY CLIENT WILL ASK MONEY FOR INTERVIEWS. NO FEES WILL BE CHARGED FOR ANY INTERVIEWS OR OFFERING YOU A JOB!!! - DON'T BE SCAMMED!!!

    Apply
    Add to favorites
    Remove from favorites
    Apply
    My Email
    By clicking on "Continue", I give neuvoo consent to process my data and to send me email alerts, as detailed in neuvoo's Privacy Policy . I may withdraw my consent or unsubscribe at any time.
    Continue
    Application form