Quality Assurance Administrator - Soweto, South Africa - AJ Personnel

AJ Personnel
AJ Personnel
Verified Company
Soweto, South Africa

1 month ago

Thabo Mthembu

Posted by:

Thabo Mthembu

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Description

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 selfmanagement 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 selfmanagement
  • 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 selfmanagement and good timemanagement skills
  • Motivated, organized, syste

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