Quality Assurance Administrator (MITS - Minimally Invasive Tissue Sampling Wits VIDA)

JustTheJob.co.za; Soweto; On-site; ZAR 250,000 - 400,000; Full time

Job summary

A leading research unit in South Africa is seeking a Quality Assurance Administrator based in Soweto. The role focuses on ensuring accuracy in data collection and adherence to regulatory protocols in clinical research. Applicants should have a National Senior Certificate and ideally possess experience in quality assurance within a research environment. This position offers the opportunity to contribute to significant health studies, enhancing the reliability of clinical trial data.

Qualifications

• Minimum 1 year experience in a research environment.
• Familiarity with electronic data capturing.
• Experience in quality assurance and clinical research is advantageous.

Responsibilities

• Ensure accuracy and reliability of data in clinical research.
• Administer quality control measures according to GCP.
• Prepare quality control findings reports and ensure compliance.

Skills

Attention to detail

Analytical thinking

Effective communication

Education

National Senior Certificate (Grade 12)

Good Clinical Practice Certificate (GCP)

Tools

Microsoft Office Excel

REDCap

Job description

Quality Assurance Administrator (MITS - Minimally Invasive Tissue Sampling Wits VIDA) - Soweto Job 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 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 cross-referencing 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 duplicated data. Resolve any QA findings by referring to relevant patient source documents or relevant medical professional for information as per 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 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 labelling 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 Take ownership of own time management and should be able to work in a pressurized environment as will be 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 for driving own career development by participating in on-going 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 Required minimum work experience : Minimum 1 year of experience in a research environment Experience in electronic data capturing Administrative experience is beneficial Minimum 1-year quality assurance experience in clinical research advantageous 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 essential Exceptional self-management and good time-management skills Motivated, organized, systematic and professional TO APPLY : Only if you do meet theminimum job requirements and experienceas mentioned above, you may submit adetailed updatedCV. Please take note that the applicants who do not adhere to the above requirements will not be considered for the respective position. Please Apply Online and complete your registration on Ditto Hire (our application tracking system) to enable and protect you as a candidate to accept the new POPIA terms and conditions. This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL. However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market. The closing date for all applications : 19 February 2025. 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 and response handling of the advertisement on behalf of their client Wits Health Consortium. AJ Personnel does not have any salary or other information regarding the position. Wits Health Consortium will only respond to shortlisted candidates. Candidates who have not been contacted within two weeks from the closing date can consider their application to be unsuccessful. Company Description The Vaccines and Infectious Diseases Analytics (VIDA) Research Unit of the University of the Witwatersrand, formerly RMPRU (Respiratory and Meningeal Pathogens Research Unit) has for over 20 years conducted numerous studies to assess the burden of and prevent vaccine-preventable diseases (VPD). Current studies and projects include infant rotavirus and BCG trials.

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Quality Administrator • Soweto, South Africa