Introduction The Perinatal HIV Research Unit (Wits PHRU) was established in 1996. The Perinatal HIV Research Unit has been involved in research, training, policy formation, and advocacy in issues concerning HIV-positive women and their children. In recent years, the work of the unit has expanded beyond the original focus of mother-to-child transmission of HIV. Description Main purpose of the job: To assist with the performance of clinical trial related duties in research studies in accordance with Good Clinical Practice (GCP) standards Location: PHRU - Tshepong Hospital, Matlosana, Klerksdorp Key performance areas: Ensure a thorough understanding of the project protocol and the SSP manuals Participate in Project Team meetings as required and provide constructive feedback and support to other team members Maintain a positive and constructive partnership with study Investigators and other site staff through constructive feedback, provision of assistance and active problem solving To conduct Quality Control activities for the clinical trials and train the site personnel in the protocol and its requirements Assist with regulatory communications, adherence, and regulatory file review Ensure all queries are attended to appropriately and in a timely manner Discuss QC trends with study team during team meetings To pay particular attention to trends in the QC findings and to conduct refresher training where necessary Ensure the defined protocol is always adhered to Ensure all required protocol parameters are always followed and recorded accurately Ensure study staff is always following study standard operating procedures Required minimum education and training: Grade 12 with Post Matric Qualification A recognized Quality Control Course (for clinical trials) Advantageous ABC of Quality Control Certificate and Good Clinical Practice Certificate (GCP) Registered with the appropriate regulatory authority. Required minimum work experience: At least 1 – 2 years' experience in quality control procedures in clinical trials At least 2 - 3 years' experience working in clinical trials Desirable additional education, work experience and personal abilities: Require good organizational, administrative, and analytical skills Excellent work ethics, interpersonal, communication and time management skills Good organizational, administrative, and analytical skills Ensure processes are conducted in accordance with Good Clinical Practice guidelines and regulations Delegation of duties Attention to detail Ability to apply consistent adherence to intentional research and GCP practices Willingness to travel to other research sites 20% of the time TO 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 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. 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: 01 August 2024. 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. We offer Medical Aid Contribution, Provident Fund Contribution
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