Quality Improvement Advisor

2 weeks ago

Parktown, South Africa AJ Personnel Full time

**Main purpose of the job**:

- To maintain a high standard of clinical quality by ensuring Quality Control activities are performed effectively, where trends are identified, coordinate relevant staff training

**Location**:

- **Ezintsha - Parktown, Johannesburg**

**Key performance areas**:

- Verify the correctness and completeness of ALL source documentation
- Ensure errors on source documents and timeously (within 24 hours) corrected, initialed, and dated by the authorized signatory
- Assist in the completion of corrective action for internal monitoring reviews - coordinate staff training (and retraining) where error trends are identified
- Assist with the review and revision of standard operating procedures per study-specific needs as needed
- Assist in electronic data clarification queries
- Perform 100% QC of all ICF documentation and maintain tracking log
- Resolve laboratory errors by timeously generating or responding to DCFs
- Review and verify CRFs and source documentation to ensure accuracy and completeness and compliance with applicable regulations
- Identify trends of inconsistencies and deviations from the requirements and regulations listed above
- Document findings relating to the monitoring of CRFs and source documents and disseminate these findings to the appropriate clinical staff
- Ensure that monitoring reports are returned timeously and include adequate documentation that findings have been resolved appropriately
- Assist in reviewing specified records prior to site audits by external monitors or inspections by other regulatory bodies
- Ensure site readiness for new protocols
- Develop tools and source documents to ensure protocols are adhered to and smooth collection of required data
- Develop and review essential study-specific documents (e.g.: SOPs, Protocol, source documentation, and lab forms)
- Produce relevant weekly reports according to project needs
- Support the ordering and control of consumable stock
- Support inventory and calibration of clinical equipment
- Timely reporting of study statistics to the study PI and team
- Assist with efficient clinic flow activities
- Take ownership and accountability for tasks and demonstrates 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 your own career development by participating in ongoing training and development activities such as conferences, workshops, etc.
- Able to work independently and as part of a team, confident to lead study QA activities from start-up to closure

**Required minimum education and training**:

- **3-year Diploma or Degree in a health-related field and/or combination of overall qualifications and experience in a similar position**

**Required minimum work experience**:

- **Minimum 5 years of clinical research experience, at least 2 years as a Quality Assurance Officer**

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

- 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 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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