Quality Assurance Administrator

2 weeks ago

Soweto, South Africa AJ Personnel Full time

**Main purpose of the job**:

- Ensuring the accuracy and reliability of data and research activities
- Ensuring protocol adherence, Case Report Form (CRF) completion, and integrity of source documentation
- Establishment and implementation of quality control measures in accordance with Good Clinical Practice (GCP)
- Assistance with all administrative aspects of clinical research projects

**Location**:

- **Chris Hani Baragwanath Academic Hospital, Soweto - Johannesburg**

**Key performance areas**:

- Quality assurance and control_
- Ability to receive, interpret, and understand different types of data and manage the data effectively
- Ability to create checklists and Quality Assurance/Enrolment logs
- Utilization of a Quality Assurance log to ensure that all goals are met and that any deviations are detected and addressed in a timely manner
- Review participant files to ensure that all documents are completed according to study protocol, that eligibility criteria are met, and that all data is correctly captured and stored on a secure platform
- Ensure that completed/reviewed files are sent to the relevant Data team timeously for capturing
- Receive Lab Requisition Forms (from CA’s) and ensure that information is accurate by crossreferencing with other documents such as the QA log
- Able to work on different databases and ensure that data is correctly stored on the shared drive (VIDA shares)
- Identification of errors and duplicate data
- Resolve any QA findings by referring to relevant patient source documents or relevant medical professionals for information as per the study protocol
- Regular review and maintenance of Quality Assurance logs
- Resolve any queries received back from the Data Team
- Implement quality improvement measures based on data analysis and feedback to enhance the reliability and efficiency of research processes
- Communicate with the entire team to optimize study productivity, appropriate and effective
- problem-solving and efficiency
- Prepare and submit reports on quality control findings, audit results, and corrective actions to the data and project manager
- Adherence to data privacy regulations and Good Clinical Practice principles in all procedures
- Administration_
- Coordination and scheduling of meetings for the internal team and with study collaborators
- Organize and maintain study documentation, including informed consent forms, participant files, and sample log
- Collect patient files from the clinical team regularly and 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
- Communication and Teamwork_
- Highly effective communication (verbal and written) with all team members
- Functioning well as a part of a team as well as individually
- Build and maintain authentic relationships with all stakeholders ensuring that all interactions are professional
- Ability to interact and establish rapport with study collaborators and external stakeholders
- Effective self-management and performance ownership_
- Good time management skills should be able to work in a pressurized environment and is required to meet deadlines
- Should be dynamic and able to fulfill different roles in the team as required
- Take ownership and accountability for tasks and demonstrate effective self-management
- Follow through to ensure that quality and productivity standards of own work are consistent
- Maintain a cheerful outlook 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**:

- **National Senior Certificate (Grade 12)**:

- **Basic Computer Literacy (Microsoft Office Excel)**

**Advantageous**:

- **REDCap Training**:

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

- **Any qualification in Business, Business Administration, or Biological Sciences**:

- **Administrative experience is beneficial**:

- **Minimum 1-year quality assurance experience in clinical research advantageous**

**Required minimum work experience**:

- **Minimum 1 year of experience in a research environment**:

- **Experience in electronic data capturing**

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

- Analytical thinking and high-level problem-solving abilities
- Excellent communication skills (verbal and written)
- Attention to detail, ability to take initiative, and conscientious work ethic is essential
- Exceptional self-management and good time-management skills
- Motivated, organized, syste

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