A Quality Assurance Administrator vacancy is available at our client, Wits Health Consortium's Perinatal HIV Research Unit (PHRU) in Kliptown, Soweto - Johannesburg. Background
The Perinatal HIV Research Unit (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, to include treatment trials in adults and children, prevention research, psychosocial research and policy development. In addition the Unit has developed an HIV vaccine clinical trials unit (HVCTU) and started with HIV Vaccine Trials back in 2001. The unit is recognised nationally and internationally as a leader in the field of research and policy in the area of mother-to-child transmission of HIV. It has also developed a reputation as a leading African research unit for clinical trials in adult and children with HIV, with one of the largest cohort.
Main purpose of the job
To review and identify any quality issues on participant files/documents before data is captured and to assist in the performance of clinical trial related duties in accordance with Good Clinical Practice (GCP)standards
Kliptown, Soweto, Johannesburg
Key performance area
To conduct Quality Control activities for the clinical trials and train the site personnel in the protocol and its requirements
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
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 adhered to at all times
Ensure all required protocol parameters are followed and recorded accurately at all times
Ensure study staff is following study standard operating procedures at all times
Required minimum education and training
Degree in Science or Social Science
Required minimum work experience
At least 1 year experience working in clinical trials
Desirable additional education, work experience and personal abilities
Require good organizational, administrative and analytical skills
Good Computer Skills
High attention to detail
Ability to apply consistent adherence to intentional research and GCP practices
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 is 11 December 2019.
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.
In accordance with our Employment Equity goals and plan, preference will be given to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.
Please note that AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
AJ Personnel does not have any salary or other information regarding the position.
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