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 effectivelyAbility to create checklists and Quality Assurance / Enrolment logsUtilization of Quality Assurance log to ensure that all goals are met and that any deviations are detected and addressed in a timely mannerReview 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 platformEnsure that completed / reviewed files are sent to the relevant Data team timeously for capturingReceive Lab Requisition Forms (from CA’s) and ensure that information is accurate by cross‑referencing with other documents such as the QA logAble 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 protocolRegular review and maintenance of Quality Assurance logs. Resolve any queries received back from the Data TeamImplement quality improvement measures based on data analysis and feedback to enhance the reliability and efficiency of research processesCommunicate with the entire team to optimize study productivity, appropriate and effective problem solving and efficiencyPrepare and submit reports on quality control findings, audit results, and corrective actions to the data and project managerAdherence to data privacy regulations and Good Clinical Practice principles in all proceduresAdministration
Coordination and scheduling of meetings for internal team and with study collaboratorsOrganize and maintain study documentation, including informed consent forms, participant files, and sample logCollect patient files from the clinical team regularly and verify patient file labelling in the filing roomManage documentation related to quality assurance, including maintaining and organising records, ensuring version control, and making documents accessible to authorized personnelMaintain comprehensive records of quality assurance activities, audit reports, corrective actions, and compliance documentationEstablish procedures for accurate and comprehensive documentation of the lab requisition form and patient files to maintain transparency and traceabilityCommunication and Teamwork
Highly effective communication (verbal and written) with all team membersFunctioning well as a part of a team as well as individuallyBuild and maintain authentic relationships with all stakeholders ensuring that all interactions are professionalAbility to interact and establish rapport with study collaborators and external stakeholdersEffective 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 deadlinesShould be dynamic and able to fulfill different roles in the team as requiredTake ownership and accountability for tasks and demonstrate effective self‑managementFollow through to ensure that quality and productivity standards of own work are consistentMaintain a cheerful outlook and respond openly to feedback
Take ownership for driving own career development by participating in on‑going training and development activitiesRequired Minimum Education and Training
National Senior Certificate (Grade 12)Basic Computer Literacy (Microsoft Office Excel)Good Clinical Practice Certificate (GCP)Any qualification in Business, Business Administration or Biological SciencesAdvantageous Qualifications
REDCap TrainingAny qualification in Business, Business Administration or Biological SciencesRequired Minimum Work Experience
Minimum 1 year of experience in a research environmentExperience in electronic data capturingAdministrative experience is beneficialMinimum 1‑year quality assurance experience in clinical research advantageousDesirable Additional Education, Work Experience and Personal Abilities
Analytical thinking and high‑level problem‑solving abilitiesExcellent communication skills (verbal and written)Attention to detail, ability to take initiative and conscientious work ethic essentialExceptional self‑management and good time‑management skillsMotivated, organized, systematic and professionalTo 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 applicants who do not adhere to the above requirements will not be considered for the position.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.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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