Quality Assurance & Quality Control Officer

QUALITY ASSURANCE AND QUALITY CONTROL OFFICER

TWO (2) YEAR FIXED TERM

J52, GROOTE SCHUUR, OBSERVATORY

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 full-time 2 year fixed-term contract position will be based at the DTHF Trials Unit in Groote Schuur in Observatory, Cape Town. The incumbent will carry out aspects of quality control and assurance, including ensuring study site compliance with required study procedures and Good Clinical Practice standards in order to verify that all research guidelines and regulations are adhered to, and data quality and data integrity  is maintained.

Minimum Requirements:

• Matric with a tertiary qualification (degree/diploma/certificate) in a Health related field or relevant other clinical research field
• At least 1-2 years’ working experience in a Clinical/Research environment
• At least 1-2 years’ experience conducting internal monitoring/quality assurance
• At least one year experience in supervising staff
• Experience in using Databases e.g. Imedidata/Inform/Redcap or similar
• Thorough understanding of RSA/ICH GCP
• Working Knowledge of procedural documents such as SOP’s, SSP’S and MOP
• Knowledge of Good Clinical Practice (GCP) guidelines and clinical trial site processes
• Understanding and knowledge of Regulatory processes
• Strong written and verbal proficiency in English
• Attention to detail
• Excellent Planning and organization abilities
• Excellent ability to build interpersonal relationships and partnerships
• Strong problem-solving and decision-making abilities
• Ability to work under pressure

Advantageous

• Previous experience in working in  Quality Control or Quality Assurance officer role or Junior CRA
• Knowledge and experience in working with  Sponsor/Funder principles and guidelines, e.g. DAIDS vs pharmaceutical
• Current GCP/HSP certification
• Proficiency in isiXhosa

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 regulatory approvals are up to date
• Review and design quality control trackers/documents
• Perform source document verification in accordance to 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 SOP’s, Study SSP’s and protocol
• Maintain site training file with training needs
• Manage the process of trainings and negotiations with sponsor regarding specific training requirements, with study coordinator and PI.
• Manage data clerks including supervision and workload distribution

 Values fit:  Passion Innovation Progress Integrity Respect Excellence

Submit CV, motivation letter with certified copy of highest qualification and details of three (3) current contactable referees in a single PDF file by 18^th November 2022 Incomplete applications will not be considered.

Visit the DTHF Career page to view the advert DTHF-C111 and apply: