Wits Health Consortium Vacancies – Quality Assurance Administrator

Job Description:

Ensure QA and QC activities performed effectively, where trends 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

Job Responsibilities:

• Ensure errors on source documents are corrected, initialled and dated by the authorized signatory
• Support the timely capturing of all Electronic Case Report Forms following QC activity
• Protocol requirements, Standard Operating Procedures (SOPs) and Regulatory Essential Documents per
• Ensure completion of corrective action of internal and external QC reports
• Assist in completion of corrective action for internal monitoring reviews
• Coordinate staff training (and retraining) where error trends are identified
• Resolve all queries raised by external monitors.
• Determine through critical review the accuracy of research records
• Compile QA/QC report/s on findings for QAO
• Monitors source queries and data entry
• Assess staff awareness and compliance to Good Clinical Practice (GCP),
• Oversee data entry
• Take ownership and accountability for tasks and demonstrates effective self-management.

Job Requirements:

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 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.

Qualification & Experience:

• 3-years diploma or degree in a health-related field
• Minimum 1-2 years relevant work experience within a clinical research environment in Quality Control and
• Required minimum education and training.

Job Details:

Company: Wits Health Consortium

Vacancy Type:  Full Time

Job Location: Parktown, Gauteng, SA

Application Deadline: N/A

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