Job Description

Main purpose of the job:

• To perform Quality Assurance duties in PHRU Matlosana in accordance with Good Clinical Practice (GCP) standards
• Ensure QA and QC activities are performed effectively across studies
• Where trends identified, coordinate relevant staff training

Location:

• Edendale Lay Ecumencial Center Clinic, Edendale, Pietermaritzburg

Key performance areas:

• Ensure a thorough understanding of the project protocol and the SSP manuals
• Attention to detail and accurate entry is critical
• Basic medical terminology and helpful for understanding case report forms (CR's) and clinical records
• Good communication skills for working with clinical staff and research coordination
• Participate in Project Team meetings as required and provide constructive feedback and support to other team members
• Maintain a positive and constructive partnership with study Investigators and other site staff through constructive feedback, provision of assistance and active problem solving
• To conduct Quality Control and Quality Assurance activities for the clinical trials, assist with regulatory communications and adherence, and train the site personnel in the protocol and its requirements
• Ensure all queries are attended to appropriately and in a timely manner
• Discuss QC trends with study team during team meetings
• To pay attention to trends in the QC findings and to conduct refresher training where necessary
• Ensure the defined protocol is always adhered to
• Ensure all required protocol parameters are always followed and recorded accurately
• Ensure study staff is always following study standard operating procedures

Required minimum education and training:

• Grade 12
• Post Matric Qualification in Health Sciences, Information Technology or related field is an advantage
• Fluent in English and IsiZulu
• Valid driver's licence and able to drive a manual vehicle
• A recognized Quality Control Course (for clinical trials) Advantageous
• Human Subjection Protection Certificate will be advantageous
• TRREE (Training and Resources in Research Ethics Evaluation) will be advantageous
• Electronic data systems (e.g RedCap) and Excel
• ALCOA + Principles
• ABC of Quality Control Certificate and Good Clinical Practice Certificate (GCP)

Required minimum work experience

• 1 - 2 year's experience in quality control procedures in clinical trials
• 1 - 2 year's experience working in clinical trial or research data capturing
• 1 - 2 year's experience in clinical data capturing

Professional body registration:

• Registered with the appropriate regulatory authority

Desirable additional education, work experience and personal abilities:

• Require good organizational, administrative, and analytical skills
• Excellent work ethics, interpersonal, communication and time management skills
• Good organizational, administrative, and analytical skills
• Ensure processes are conducted in accordance with Good Clinical Practice guidelines and regulations
• Delegation of duties
• Ability to apply consistent adherence to intentional research and GCP practices
• Willingness to travel to other research sites 20% of the time

TO APPLY:

• Only if you meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV
• Please Apply Online and complete your registration via our website to enable and protect you as a candidate, and to accept the new POPIA terms and conditions
• This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL
• However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market
• Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position
• Wits Health Consortium will only respond to shortlisted candidates
• Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful
• Closing date: 11 July 2025
• Note: No CV will be accepted after the closing date

Please note:

• WHC, in accordance with its Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto
• AJ Personnel is only responsible for advertising and the response handling on behalf of their client Wits Health Consortium
• AJ Personnel does not have any salary or other information regarding the position