Quality Assurance Administrator
Soweto


A leading Research center that is at the forefront of research, training and advocacy for HIV positive South African’s is currently looking for a dynamic and driven Quality Assurance Administrator based in Soweto.

he Quality Assurance Administrator is responsible for the quality control and quality assurance of the research data and protocol-specific data management systems and to adhere to the Data Management policy documents and Standard Operating Procedures.
The Quality Assurance Administrator also participates in the ongoing monitoring of the research studies at the Bio-Behavioural Research Department.

Education, Training and Experience
• Matric
• A university degree or diploma/certification in a related field
• At least 1 years’ experience in quality control procedures in clinical research
• At least 1 years’ experience working in clinical research environment
• Strong organizational, administrative and analytical skills
• Possess strong oral and written communication skills
• Maintain a high level of accuracy and high attention to detail
• High Level of Computer literacy.
• Ability to work independently and in a research team
• Ability to work in a highly stressful environment

Key performance areas

• Ensure a thorough understanding of the project protocol, standard operating procedures and study specific procedures manuals
• Participate in project team meetings as required and provide constructive feedback and support to other team members
• To conduct Quality Control activities for the clinical research, assist with regulatory communications and adherence, and train the site personnel in the protocol and its requirements
• Ensure all queries are attended to by the research team appropriately and in a timely manner
• To pay particular attention to trends in the QC findings and to conduct refresher training where necessary
• Data capturing and data management
• Perform pre-initiation validation of CRFs and database applications.
• Ability to understand, implement and ensure continued compliance with the data flow management and reporting requirements
• Ensure development of tracking tools and checklists to assist sites with data flow management
• Prepare reports as required by Sponsors, Stakeholders, Project Director and Project Manager
• Ensure the defined protocol and Good Clinical Practice is adhered to at all times
• Ensure all required protocol parameters are followed and recorded accurately at all times
• Ensure study staff is following data specific standard operating procedures and study specific procedures at all times
• Maintain a positive and constructive partnership with study Investigators and other site staff through constructive feedback, provision of assistance and active problem solving
• Ability to interact and collaborate with internal and external stakeholders (funders) to understand data specifications and requirements