Description:
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
03 Jul 2025;
from:
gumtree.co.za