Main purpose of the job:To assist with the performance of clinical trial-related duties ensuring protocol adherence, legibility, completeness, and consistency of data by being responsible for internal monitoring, validation, and auditing of participants’ source documents, CRF files, and site filesTo perform quality assurance activities in accordance with the Site’s Quality Management Plan, Sponsor regulatory requirements, and ICH GCP requirementsCase Report Form completion and adherence regarding source documentation as in accordance with Good Clinical PracticeLocation:PHRU – Chris Hani Baragwanath Hospital, Soweto - JohannesburgKey performance areas:Review and verify CRFs and source documentation to ensure accuracy, completeness, and compliance with applicable regulationsIdentify trends of inconsistencies and deviations from the requirements and regulationsGenerate monthly monitoring reports that included a quantitative and qualitative review of source documentation and CRFs monitoredDocument findings relating to the monitoring of CRFs and source documents and disseminate these findings to the appropriate clinical staffAssist staff with GCP and audit-compliant resolution of all monitoring findingsEnsure that there is adequate documentation that findings have been resolved appropriately and timeouslyAssist in reviewing specified records prior to site monitoring visits, audits, or inspectionsReview Site Monitoring Reports generated by monitors to assist in identifying trends and errors in completing CRFs and source documents and apply this knowledge to improve subsequent monitoringProvide training on the broad trends identified during internal and external monitoringCreate, amend, and provide staff with tools: i.e. checklist and tracking logs to ensure the prevention of errorsComplete the Clinical Quality Management Plan (CQMP) document in consultation with management taking into account donor requirements and specificationsEstablish through the CQMP clearly defined Quality Control Procedures and policies for the entire teamEnsure that the CQMP is adhered toEnsure site readiness for new protocolsDevelop tools and source documents to ensure protocols are adhered to and a smooth collection of required dataReview site investigator files to ensure all relevant documents are filed and maintained accordinglyEnsure that all requirements for study activation have been met, documented, and filed appropriatelyEnsure that all required training is completed and documentedRequired minimum education and training:Minimum of a Bachelor's Degree, in a Science or Health Science disciplineCRA (Clinical Research Associate) training would be advantageousRequired minimum work experience:At least 1 year of experience within the research fieldDesirable additional education, work experience, and personal abilities:Meticulous attention to detailLogical thinker with an ability to work independently within a team environmentProactive, enthusiastic with good time management skillsAbility to apply consistent adherence to intentional research and GCP practicesIntermediate Computer SkillsThe ability to establish and maintain effective working relationships with internal stakeholdersEffective Written and Verbal communication at all levelsExcellent reporting skillsAble to work under pressure in a high-cognitive environmentTO 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: 24 May 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.