Quality Assurance Officer (QA) - Wits ILTBRU

SUMMARY:
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POSITION INFO:

Main purpose of the job:

To assist with the performance of the program and clinical trial-related duties in line with Good Clinical Practice (GCP) standards and be responsible for (1) internal monitoring and validation of patient files to ensure completeness and data consistency and (2) compiling of site regulatory and essential documents to all required stakeholders: Ethics Committees, South African Health Products Regulatory Authority, and other regulatory bodies

Location:

Johannesburg, Durban, and Gqebertha

Key performance areas:

• Ensure a thorough understanding of the project protocol
• 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
• Conduct Quality Control activities for the program and/or clinical trials, assist with regulatory communications and adherence and train the site personnel in the protocol and its requirements
• Review and Assess Case Report Forms, Informed Consents and Standard Operating Procedures
• Ensure all queries are attended to appropriately and in a timely manner
• Discuss QC trends with the study team during team meetings
• Pay particular attention to trends in the QC findings and to conduct refresher training where necessary
• Ensure the defined protocol is adhered to at all times
• Ensure all required protocol parameters are followed and recorded accurately at all times
• Ensure study staff is following study standard operating procedures at all times
• Assist with preparation and follow-up of external monitoring visits and audits
• Training/corrective action for site staff based on QC/QA/External monitoring findings in conjunction with Managers
• Report and track critical events and protocol deviations as notifications occur
• Develop and/or review study-specific SOPs when required
• Prepare site regulatory and essential documents in a timeous and accurate manner to all applicable ethics, regulatory bodies, and sponsors
• Track submissions and approval status
• Maintain regulatory documents
• Conduct internal monitoring of regulatory files
• Generate regulatory reports as required
• Communication with internal and external stakeholders
• Travel to program sites frequently (at least monthly)

Required minimum education and training:

• Degree or Diploma in Health Care or other Scientific Discipline
• GCP qualification
• A recognized Quality Control Course (for clinical trials)
• Computer literacy at a higher level including the use of MS Word, Excel and Email and the Internet

Required minimum work experience:

• At least 3 years experience in quality control procedures in clinical trials
• At least 5 years experience working in clinical trials
• At least 2 years regulatory experience

Desirable additional education, work experience, and personal abilities:

• Require good organizational, administrative, and analytical skills
• Time Management
• Extremely well organized and resourceful
• Analytical Ability
• Ability to work independently
• Ability to work in a high-pressure environment
• Delegation
• Attention to detail
• Ability to apply consistent adherence to intentional research and GCP practices
• Ability to communicate effectively within study team and with external stakeholders
• Very time conscious
• Flexible and ability to multitask
• Work independently

TO APPLY:

• Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
• Please Apply Online and complete your registration on Ditto Hire (our application tracking system) to enable and protect you as a candidate 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.
• AJ Personnel is fully POPIA Compliant.
• Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
• The closing date for all applications: 10 November 2021
• 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.
• Note WHC, in accordance with their 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.

Please note:

• AJ Personnel is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
• AJ Personnel does not have any salary or other information regarding the position.

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NB! This job is now closed. You can apply for other jobs by uploading your CV.