QA/QC INTERNAL MONITOR

QA/QC INTERNAL MONITOR
FIXED-TERM CONTRACT
WOODSTOCK

The Desmond Tutu Health Foundation (DTHF) is a registered non-profit organisation focused on the pursuit of excellence in research, treatment, training and prevention of HIV and related infections in Southern Africa.

We have fantastic job opportunities across our businesses for talented people wanting to realize their full potential. Could that be you? If so, we invite you to explore the possibility of joining us to play your part in Desmond Tutu Health Foundations exciting future.

This position requires will be to carry out aspects of quality assurance, including auditing study team compliance with required study procedures and Good Clinical Practice standards in order to verify that all research guidelines and regulations are adhered to.

Minimum Requirements:
Matric with a tertiary qualification in a Health related field or relevant qualification
At least 3 years experience conducting internal monitoring and quality assurance
Source Data Verification including Remotely, using Databases e.g. Imedidata
Demonstration of Sponsor/Funder principles and guidelines, e.g. DAIDS
Working Knowledge of procedural document such as SOPs, SSPS and MOP
Knowledge of Good Clinical Practice (GCP) guidelines and clinical trial site processes
In depth understanding and knowledge of Regulatory Guidelines
Strong written and verbal proficiency in English and other local languages
Valid GCP certification
Excellent ability to build interpersonal relationships and partnerships
Strong problem-solving and decision-making abilities
Ability to work under pressure
Attention to detail
Excellent Planning and organization abilities
Willingness to travel to sites locally
Responsibilities:
Assist by Providing input regarding CRS clinical quality management plan development and implementation, in line with NIH DAIDS Clinical Quality Management Plan and other requirements by funders
Ensure all the HREC Approvals are in place
Regulatory, SAHPRA, Approvals are in place
Ensure that a confirmation letter is sent to site prior to visit, confirming auditing visit activities
Review protocol deviations
Review regulatory trackers and give input for the design thereof
Ensure corrective action is implemented timeously
Perform source document verification in accordance with protocol needs and Quality management plan.
Review Case Report Forms (CRFs) and Electronic Data Completion (EDC)
For completeness and accuracy and ensure that corrections are made appropriately.
Review and report outstanding issues at the site, for example Serious Adverse Events (SAEs), adherence to protocol and data quality issues.
Compliance verification to approved study protocol
Adherence to RSA and ICH GCP by sites in conducting studies
Verify study conduct in accordance with site SOPs, Study SSPs and