Main purpose of the job:To assist with the performance of clinical trial-related duties in line with Good Clinical Practice (GCP) standards and be responsible for internal monitoring and validation of participant files to ensure completeness and data consistency and compiling of site regulatory and essential documents to all required stakeholders: Ethics Committees, South African Health Products Regulatory Authority and other regulatory bodiesEnsure compliance with regulatory requirements within research studiesLocation:ILTBRU, Jose Pearson TB Hospital, Gqeberha (Port Elizabeth)Key performance areas:Conduct Quality Control activities for clinical trials, assist with regulatory communications and adherence, and train the site personnel in the protocol and its requirementsReview and Assess Case Report Forms, Informed Consents, and Standard Operating ProceduresEnsure all queries are attended to appropriately and in a timely mannerDiscuss QC trends with the study team during team meetingsPay particular attention to trends in the QC findings and to conduct refresher training where necessaryEnsure the defined protocol is adhered to at all timesEnsure all required protocol parameters are followed and recorded accurately at all timesEnsure study staff is following study standard operating procedures at all timesAssist with the preparation and follow-up of external monitoring visits and auditsTraining/corrective action for site staff based on QC/QA/External monitoring findings in conjunction with ManagersReport and track critical events and protocol deviations as notifications occurProvide expert guidance on the requirements of local and international regulatory bodies and frameworks, and support the department to comply with those requirementsSupport drafting and submissions of technical reports to IRBs, SAHPRA, and sponsors as neededUpdate site delegation logs when new staff joinEnsure adequate training is completed by new staff members and training logs completedEnsure staff adhere to responsibilities defined in site delegation logs per qualifications and trainingDevelop and/or review study-specific SOPs when requiredPrepare site regulatory and essential documents in a timeous and accurate manner to all applicable ethics, regulatory bodies, and sponsorsTrack submissions and approval statusMaintain regulatory documentsConduct internal monitoring of regulatory filesGenerate regulatory reports as requiredCommunication with internal and external stakeholdersSchedule and facilitate trainingTraining/corrective action for site staff based on QC/QA/External monitoring findings in conjunction with ManagersTake ownership and accountability for tasks & activities and demonstrate effective self-managementFollow through to ensure that quality and productivity standards of own work are consistently and accurately maintainedInform relevant parties in the event of tasks or deadlines not met and provide appropriate means of resolutionSupport and drive the business's core valuesMaintain a positive attitudeRespond openly to feedbackTake ownership of own career developmentManage colleagues' and client's expectations and communicate appropriatelyWilling to help others and go the extra mile to meet team targets and objectivesManage own disruptive emotions (handle stress in ways that do not negatively impact the team)Ensure all interactions with both internal and external customers are handled professionallyRequired minimum education and training:Degree in Health Care or Life SciencesGCP qualificationA recognized Quality Control Course (for clinical trials)Computer literacy at a higher level including the use of MS Word, Excel, Email, and InternetRequired minimum work experience:3 years of quality control experience in a clinical trial environmentAt least 5 years experience working in clinical trialsAt least 2 years of regulatory experienceDesirable additional education, work experience, and personal abilities:Require good organizational, administrative, and analytical skills, time management, and extremely well-organized and resourcefulAnalytical ability, ability to work independently, ability to work in a high-pressure environment, delegation, attention to detail, ability to apply consistent adherence to intentional research and GCP practicesAbility to communicate effectively within study team and with external stakeholders, very time conscious, flexible, and able to multitask, work independentlyTO 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: 23 April 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.
