Main purpose of the job:Ensure QA and QC activities are performed effectively across studies where trends are identified, coordinate relevant staff trainingLocation:22 Esselen Street, Hillbrow, JohannesburgKey performance areas:Determine through critical review the accuracy of research recordsEnsure errors on CRFs and relevant databases are corrected, initialed and dated by the authorized signatoryEnsure completion of corrective action of internal and external QC reportsEnsure the site is well prepared for external lab, clinical, social science, and community monitoring reviewsAssist in the completion of corrective action for monitoring reviewsAssist/ensure completion of corrective action for internal monitoring reviews in a timely mannerCompile QA/QC report/s on findings for the site management teamSupport the Regulatory/Data team with periodic quality assurance activitiesReview and ensure essential regulatory documentation available and up to date across all studiesAssist with the review and revision of standard operating procedures per study-specific needs as neededAssess staff awareness and compliance to Good Clinical Practice (GCP), Protocol requirements, Standard Operating Procedures (SOPs), and Regulatory Essential Documents per sponsor requirementsCoordinate staff training (and retraining) where error trends are identifiedTake ownership and accountability for tasks and demonstrate effective self-managementFollow through to ensure that quality and productivity standards of own work are consistently and accurately maintainedMaintain a positive attitude and respond openly to feedbackTake ownership of driving your own career development by participating in ongoing training and development activities such as conferences, workshops, etc.Required minimum education and training:3-year Diploma or Degree in a Health-related fieldRequired minimum work experience:Minimum 1-2 years of relevant work experience within a clinical research environment in Quality Control and Quality AssuranceDesirable additional education, work experience, and personal abilities:A postgraduate degree would be an added advantageExtensive understanding of the research language, detailed knowledge, and understanding of the relevant studies and SOPs, knowledge of clinical research documentationComputer literate with the ability to create or work with databasesFluent in English, fluency in one of the other official SA languages particularly Zulu or Sesotho would be an added advantageGood written and verbal communication skillsStrategic thinking and problem-solving skillsConscientious and precise delivery of work even when under pressureEffective self-management, resourcefulness, and initiative to solve problemsExcellent communication and presentation skillsTO APPLY:Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.Please Apply Online.Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.The closing date for all applications: 07 June 2024.Note AJ Personnel is fully POPI compliant.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 of the advertisement on behalf of their client Wits Health Consortium.Wits Health Consortium will only respond to shortlisted candidates. Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful.AJ Personnel does not have any salary or other information regarding the position.