Job Description

Main purpose of the job:

• Ensure QA and QC activities are performed effectively, where trends are identified, coordinate relevant staff training
• Maintain Regulatory Documents and assist with periodic review and revision of SOPs
• Oversee Electronic Data Capturing (EDC) process including query resolution

Location:

• 32 Princess of Wales Terrace, Parktown - Johannesburg

Key performance areas:

• Assist with the review and revision of standard operating procedures per study-specific needs as needed
• Verify the accuracy of data from source documentation to the EDC system
• Ensure errors on source documents are corrected, initialed, and dated by the authorized signatory
• Support the timely capturing of all Electronic Case Report Forms following QC activity
• Ensure completion of corrective action of internal and external QC reports
• Assist in the completion of corrective action for internal monitoring reviews
• Monitors source queries and data entry errors and facilitates appropriate training
• Assess staff awareness and compliance to Good Clinical Practice (GCP), Protocol requirements, Standard Operating Procedures (SOPs), and Regulatory Essential Documents per sponsor requirements, specifically Electronic Data Capture (EDC) guidelines
• Determine through critical review the accuracy of research records
• Compile QA/QC report/s on findings for QAO
• Coordinate staff training (and retraining) where error trends are identified
• Resolve all queries raised by external monitors
• Oversee data entry

Required minimum education and training:

• 3-year Diploma or Degree in a Health related field

Required minimum work experience:

• Minimum 1-2 years of relevant work experience within a Clinical Research environment in Quality Control and Quality Assurance

Desirable additional education, work experience, and personal abilities:

• A postgraduate 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 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

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: 28 September 2023.
• Note AJ Personnel is fully POPI compliant.
• Note WHC, in accordance with their Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.

Please note:

• AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
• 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.
• AJ Personnel does not have any salary or other information regarding the position.

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