QAqc Internal Monitor

2 weeks ago

City of Cape Town Western Cape, South Africa Desmond Tutu HIV Foundation Full time

**Overview**:
**Reference**
DTHF-009

**Salary**
Not Applicable

**Job Location**:

- South Africa - City of Cape Town Metro

**Job Type**
Contract

**Posted**
Wednesday, February 01, 2023

**Closing date**
15 Feb 2023 23:59

**QAQC INTERNAL MONITOR**

**FIXED- TERM CONTRACT - End Date 30 November 2027**

**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.

**Minimum Requirements**:

- Matric with a tertiary qualification in a Health related field
- At least 2-4 years’ working experience in a Clinical/Research environment
- At least 2-3 years’ experience conducting internal monitoring/quality assurance/quality control
- Experience in using Databases e.g. Imedidata
- Valid driver's license
- Knowledge of Sponsor/Funder principles and guidelines, e.g. DAIDS
- Working Knowledge of procedural document such as Standard Operating Procedure (SOP), Study Specific Procedures (SSP) and Manual of Operational Procedures ( MOP)
- In depth knowledge and understanding of Good Clinical Practice (GCP) guidelines, SA GCP as well as clinical trial site processes.
- In depth understanding and knowledge of Regulatory and Ethics Guidelines
- Strong written and verbal proficiency in English and other local languages
- Strong client focus
- 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 clinical quality management plan development and implementation, in line with NIH DAIDS Clinical Quality Management Plan and other requirements by funders and regulators.
- Review all the HREC and SHAPRA approvals and communication to ensure that all applicable approvals and notifications are in place.
- Follow the monitoring plan for the study, site and or DTHF.
- Log and review protocol deviations and suggest corrective and preventative actions.
- Ensure corrective action is implemented timeously
- Perform source document review and verification in accordance with SA/ GCP, protocol and Quality management plan.
- Review e CRF /Case Report Forms (CRFs) and Electronic Data Capture (EDC), for completeness and accuracy ( ALCOA + principals) 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 SA GCP and ICH GCP by sites in conducting studies
- Verify study conduct in accordance with site SOP’s, Study SSP’s and protocol

**Values fit: Passion Innovation Progress Integrity Respect Excellence**

**Visit the DTHF Career page to view the advert DTHF-008 and apply**:DTHF Career Page
- _
- I further understand that the personal information I disclose to DTHF will be processed in accordance with the requirements set out in the Protection of Personal Information Act and may include the transferring thereof to third parties for the purposes of verification._
- _
- This job may be removed before it expires._
- Desmond Tutu Health Foundation is a child-friendly organisation committed to the protection of children._

**For more information about the organization please visit our website.

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