The Aurum Institute is offering a great opportunity to suitably qualified and experienced staff to contribute towards our mission to improve the health of people and communities through preventive research in communicable diseases.
\nCurrently we are focused on vaccine researching, supporting and implementing integrated approaches to managing COVID-19, RSV, Gonorrhoea Infection and HIV.<\/p>\n
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Job Title: Quality Officer – Tembisa<\/strong> Job Summary:<\/strong> YOUR JOB WILL BE:<\/strong> YOU SHOULD HAVE:<\/strong><\/p>\n Education:<\/strong> Work Experience: Other:<\/strong> These appointments are subject to the preferred candidates obtaining the necessary security clearance, reference checking and competency assessment. We embrace employment equity and are committed to achievement of fair and equal representation of our workforce. Preference will be given to internal applicants and candidates from previously disadvantaged backgrounds. Whilst all applications will be carefully considered, only short-listed applicants will be interviewed. If you do not hear from us within 21 days of the closing date, this will mean that your application has been unsuccessful. All interviewed applicants will receive feedback as part of our continued drive towards people development.<\/p>\n
\nLocation:<\/strong> Tembisa, Gauteng, South Africa
\nReference #:<\/strong> 2022\/03\/23\/04
\nContract Type:<\/strong> Permanent
\nSalary:<\/strong> Market Related<\/p>\n
\nThe Quality Control Officer is responsible for overseeing the review systems, processes and documentation necessary to ensure high quality data is collected<\/p>\n
\nConducting in-house monitoring to ensure compliance with ICH\/GCP, standards, Protocol and other Guidelines as applicable.
\nEnsure that all staff are using current versions of Study documents, e.g. Protocol specific documents, program specific documents.
\nData verification of source data and relevant documents e.g. CRF\u2019s, and other data collection forms.
\nGive ongoing feedback on type of findings\/trends etc.
\nIdentify training needs in, and give feedback to the relevant Study Coordinator\/Programme Manager.
\nDeveloping and maintaining systems to ensure that correct data is collected by relevant staff
\nRaising study related queries with the Quality Manager, Principal Investigator, Programme Manager and Study Coordinator to ensure clean and accurate data
\nReview project developed source documentation.
\nProvide training on quality related topics.
\nPrepare for monitoring visits
\nSOP\/WPG review and writing as applicable
\nReview corrective\/preventive actions
\nAssisting the Quality Manager in implementing the Quality Management Plan
\nPerforming other duties as delegated by the Quality Manager
\nEnsuring version control of study documents
\nEnsuring timely reporting of all project activities using predefined indicators
\nPerforming quality control of recording and reporting procedures including checking data collection tools for accuracy
\nApply national and International legislation(s) pertaining to research
\nAbility to generate reports from Excel Data
\nConducting QC1, QC2 and data verification activities
\nRequirements: <\/strong><\/p>\n
\nRelevant degree\/diploma in Health, Sciences or Social Sciences or equivalent education
\nValid GCP certificate<\/p>\n
\nAt least 2 years clinical research experience
\nPrevious work experience in a quality assurance\/control environment advantageous
\nProficiency in written and spoken English<\/p>\n
\nValid Driver\u2019s license
\nOwn transport advantageous
\nAbility to work independently and in a team
\nOpen and clear communicator
\nFocused on quality and detail
\nWorking Knowledge of MS Packages
\nDeadline orientated
\nAbility to work under pressure
\nAttention to detail
\nProactive<\/p>\n
\nAurum welcomes applications from all persons with disabilities<\/p>\n