Quality Assurance

1 month ago

Durban, South Africa AJ Personnel Full time

**Job Requirements**:
**Qualifications and experience**:

- **A relevant 3-year degree or Diploma in Health or Social Science or similar relevant qualification or higher**
- **At least 3 years clinical research experience**
- **At least 1-2 years’ experience with quality assurance activities in clinical trials**
- **A broad knowledge of TB and HIV/AIDS would be advantageous**
- Proficiency in MS Office (Word, Excel, Outlook, and PowerPoint
- Knowledge of ICH/SA GCP Guidelines

**Personal Qualities and Competencies**:

- Ability to use initiative, prioritize, multi-task and work well under pressure to meet deadlines in a fast paced and dynamic environment
- Analytical ability and problem solving
- Attention to detail
- Strategic thinking
- Effective organizational****:

- Communication and interpersonal skills** **Excellent computer skills in MS Office packages** **- Ability to maintain a high degree of professionalism and confidentiality

**Key Responsibilities**:

- Perform monitoring and co-monitoring visits of multiple studies at all the Clinical Research Sites.
- Perform QA Review visits of multiple studies at all the Clinical Research Sites.
- Verifying that data generated is consistent with source and Case Report Forms
- Assist with study activation, site initiation and study close out activities at the sites
- Submitting detailed, timely monitoring and co-monitoring reports to the study teams and debrief study investigators and site staff on common

findings and trends
- Assist with preparation for external audits, inspections and monitoring
- Perform reviews of the Investigator Site Files and Trial Master Files
- Maintain quality of clinical trial by ensuring compliance with the study protocol, ICH/SA GCP guidelines, institutional SOPs, IRB regulations, and FDA

regulations.

**Location**:
Durban - KZN

**TO APPLY**:

- **Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.**:

- **_AJ Personnel is fully POPIA Compliant._**:

- **Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.**:

- **Note our clients may expire jobs at their own discretion.**:

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