Quality Assurance Administrator

2 weeks ago

Soweto, South Africa AJ Personnel Full time

**Main purpose of the job**:

- To ensure the integrity, compliance, and accuracy of research activities and data
- To oversee adherence to regulatory standards, ensure data integrity, and implement quality control measures by Good Clinical Practice

**Location**:

- **Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit - Chris Hani Baragwanath Academic Hospital, Soweto - Johannesburg**

**Key performance areas**:
**_ Quality assurance and control_**
- Data review_
- Daily review of the RedCap Enrolment Log to ensure that all fields are correctly captured i.e., Hospital no; study ID; and enrolment criteria and status (eligible; enrolled)
- Receive Lab Requisition Forms from RAs to check that all identifiers are correctly captured and crosscheck that the PET and hospital numbers are correct on the enrolment log
- Review the data captured in the enrolment Log and PNS Database, storage, and retrieval processes of patient files to maintain data integrity and security, while adhering to data privacy regulations and GCP
- Monitoring and Auditing_
- Conduct regular monitoring and auditing of the PNS Database, including data verification, run data quality rules to check for duplicates and ensure protocol adherence
- Data Validation_
- Implement data validation procedures to verify the completeness, and reliability of the PNS data, preventing errors or data inaccuracies
- Continuous Improvement_
- Implement quality improvement measures based on data analysis and feedback to enhance the reliability and efficiency of research processes
- Collaboration_
- Communicate with all relevant departments (such as but not limited to the laboratory and field or clinical teams) to ensure study productivity, appropriate and effective problem-solving, and efficiency
- Reporting_
- Prepare and submit reports on quality control findings, audit results, and corrective actions to the data and project manager

**_Administration_**
- Organize and maintain study documentation, including informed consent forms, participant files, and sample log
- Collect patient files from the clinical team from their office once a week
- Verify patient file labeling in the filing room
- Manage documentation related to quality assurance, including maintaining and organizing records, ensuring version control, and making documents accessible to authorized personnel
- Maintain comprehensive records of quality assurance activities, audit reports, corrective actions, and compliance documentation
- Establish procedures for accurate and comprehensive documentation of the lab requisition form and patient files to maintain transparency and traceability

**_Customer Service_**
- Ensure all customer interaction (Both internal and external customers) is of the highest professional level
- Build and maintain authentic relationships with all stakeholders ensuring that all interactions are professional

**_Effective self-management, and performance ownership_**
- Take ownership and accountability for tasks and demonstrate effective self-management
- Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
- Maintain a positive attitude and respond openly to feedback
- Take ownership of driving own career development by participating in ongoing training and development activities

**Required minimum education and training**:

- **Matric/Grade 12**:

- **Good Clinical Practice (GCP) Certification**:

- **REDCap training is essential**

**Required minimum work experience**:

- **2 years experience in a research environment**:

- **Minimum 1-year quality assurance experience in a research environment**:

- **Experience in electronic data capturing**

**Desirable additional education, work experience, and personal abilities**:

- Good verbal and written communication skills Basic computer literacy
- High-level problem-solving ability needed
- Exceptional self-management
- Conscientious work ethic
- Above-average attention to detail required
- Motivated, organized, systematic and professional
- Should be able to work under pressure with efficient multitasking

**TO APPLY**:

- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- 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.**:

- **AJ Personnel does not have any salary or other information regarding the position.

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