Quality Assurance Officer (WITS RHI)

Main purpose of the job

• To ensure QA and QC activities are performed effectively across studies • Identify trends and coordinate relevant staff training Location:

• 7 Esselen Street, Hillbrow, Wits RHI Research Centre Clinical Research Site (CRS) Key performance areas:

• 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 • Assist Regulatory Compliance Officer with QA of regulatory files • Verify transcription and accuracy of data from source documentation to Case Report Forms (CRF) • Ensure errors on CRFs are corrected, initialled and dated by the authorized signatory • Support the timely capturing of all Case Report Forms following QC activity • Ensure completion of corrective action of internal 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 all ICFs and other source documents to ensure accuracy and completeness • Timeous reporting to study PI and study coordinator Regulatory Compliance Officer regarding QC and major issues such as protocol deviations • Perform duties per study Delegation of Authority Logs • Support Regulatory Compliance Officer 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 • Coordinate staff training (and retraining) where error trends are identified • Ensure 100% QA of ICFs • Ensure site is well prepared for external lab, clinical, social science, and data monitoring reviews • Assist sponsors/monitors before, during and after the review • Assist regulatory compliance officer, project managers/team in completion of corrective action for external monitoring reviews/audits and inspections Required minimum education and training:

• 3-year Diploma or Degree in a Health related field Required minimum work experience:

• Minimum 1-2 years 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 Deg

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