Quality Assurance Manager

2 weeks ago


Hillbrow, South Africa AJ Personnel Full time

**Main purpose of the job**:

- Coordinate the quality assurance (QA), quality control (QC), data processing, and data management activities of a research project such as developing standard operating procedures, overseeing/coordinating QA/QC activities, data capturing, and providing analysis output and training

**Location**:

- **Wits RHI - 7 Esselen Street, Hillbrow - Research Centre - Johannesburg**:

- **On the 3rd ,4th, and 5th Floor**

**Key performance areas**:

- Coordinate QC activities of the QA/QC officers
- Assist with QC when required
- Verify transcription and accuracy of data from source documentation to case report forms (CRFs)
- Ensure errors on CRFs are corrected, initialed, and dated by the authorized signatory
- Support the timely transmission/data faxing/data entry of relevant CRFs following QC activity (as needed)
- QC of informed consent forms (ICFs) and other source documents to ensure accuracy and completeness
- Ensure completion of corrective action for internal QC reports or error trends identified during QC
- Coordinate staff training and retraining where error trends are identified
- Ensure timeous reporting of QC trends and issues to the investigator of record (IoR), principal investigator (PI), program manager (PM), or study coordinator (SC) as applicable
- Conduct periodic quality assurance activities as per the Clinical quality management plan (CQMP) to evaluate the quality and integrity of the research data and ensure that error correction and documentation standards are being adhered to
- Assess staff awareness and compliance to good clinical practice, protocol requirements, standard operating procedures, and regulatory essential documentation per sponsor requirements (including 5 record reviews for new staff)
- Identify and ensure compliance with regard to safety reporting and reporting of endpoints (e.g. EAE, SAE and pregnancies)
- Determine, through critical review, the accuracy of research records
- Compile QA/QC reports or findings for the site management team
- Assist in the completion of corrective action for internal monitoring reviews
- Coordinate staff training and retraining where error trends are identified
- Ensure 100% QA of informed consent forms (ICFs)
- Review source data templates for new protocols
- Assist regulatory compliance officer (RCO) with regular quality assurance of regulatory files to ensure that the study has all essential regulatory documentation on file
- Assist with the review and revision of standard operating procedures per study-specific needs as required
- Review clinical trial data and ensure compliance with protocol requirements
- Evaluate the quality and integrity of the source document and CRFs to related protocol adherence and compliance with local regulations (HREC, SAHPRA, SA GCP, and ICH/GCP)
- Prepare cases (source and CRF) for audit purposes
- Create and maintain appropriate documentation regarding internal monitoring findings.
- Review and prepare files for external monitoring
- Provide technical input into research tool and database design, analysis, and interpretation of data
- Develop and implement data management work plans
- Delegate and oversee data capturing and assist as needed
- Raise and resolve data queries will clinic staff
- Provide support to relevant study staff
- Develop implement and maintain data-related SOPs
- Quality assures that all data is in accordance with ethical and GCP requirements as well as SOPs
- Monitor and evaluate the progress of data management for respective projects
- Process and produce accurate data reports within required timeframes
- Compile monthly, quarterly or annual progress reports as required
- Oversee the maintenance of participant files and archiving
- Participate in and represent the data management team at meetings as required
- Ensure the site is well prepared for external laboratory, clinical, social science, and data monitoring reviews
- Assist sponsors/monitors/auditors before, during, and after the monitoring/audit review
- Assist staff with the completion of corrective action for external monitoring reviews/audits and inspections
- Attend and contribute to protocol-specific and organizational meetings
- Provide monthly updates on monitoring and error trends to the site leadership and the organizational QA group
- Provide training to staff with regard to ongoing error or omission trends if required
- Attend to all staffing requirements and administration
- Supervise and manage the duties of subordinates to ensure optimal staff utilization and maintenance of sound labor relations
- Perform and facilitate performance development and assessments
- Identify substandard performance by team members and take necessary corrective action
- Coach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organization
- Promote harmony, teamwork, and sharing of information
- Take ownership and accountability for tasks and demonstrates


  • Data Manager

    1 day ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Manage all data-related activities in the CRS, including database design, writing and implementing standard operating procedures, quality assurance, management of project dashboards, and analysis **Location**: - **Hillbrow - Johannesburg** **Key performance areas**: - Provide technical input into research tools, database...

  • Data Manager

    4 days ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Coordinate the data processing and management activities of research projects such as developing standard operating procedures, overseeing data capturing, preparing and designing databases and performance dashboards, and establishing data quality control tools **Location**: - **Hillbrow - Johannesburg** **Key performance...


  • Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Ensure QA and QC activities performed effectively across studies **Location**: - **Wits RHI - 7 Esselen Street, Hillbrow, Research Centre - Johannesburg**: - **On the 3rd,4th, and 5th Floor** **Key performance areas**: - Review and ensure that the study has all essential regulatory documentation through routine updates as...


  • Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Operate ultrasound equipment to acquire, interpret and record anatomical images to assist with gestational age estimates of pregnant women **Location**: - **7 Esselen Street, Hillbrow - Johannesburg** **Key performance areas**: - Determining the number of fetuses and obtaining measurements of standard fetal planes - these...

  • Internal Monitor

    7 days ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To ensure legibility, completeness, and consistency of data by being responsible for internal monitoring, validation, and auditing of participant’s source and CRF files - To perform quality assurance activities in accordance with the unit’s Quality Assurance Plan, Sponsor regulatory requirements, and ICH GCP...


  • Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To support formalizing research collaboration, data acquisition, and data protection for research conducted across the sub-Saharan African continent, as part of the Heat and Health Transdisciplinary (HEAT) Center **Location**: - **22 Esselen and Klein Street, Hillbrow - Johannesburg** **Key performance areas**: - Lead and...

  • Research Coordinator

    8 hours ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To support formalizing research collaboration, data acquisition, and data protection for research conducted across the sub-Saharan African continent, as part of the Heat and Health Transdisciplinary (HEAT) Center **Location**: - **22 Esselen and Klein Street, Hillbrow - Johannesburg** **Key performance areas**: - Identify...

  • Professional Nurse

    5 days ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Provide comprehensive quality HIV and Primary Health Care services to transgender people within fixed and mobile clinical settings **Location**: - **Hillbrow, Johannesburg** **Key performance areas**: - Provide comprehensive gender-affirming clinical services within a multi-disciplinary team - Provide HIV Counselling and...


  • Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To implement pharmaceutical services as per protocols for clinical research studies conducted at Wits RHI research sites **Location**: - **Wits RHI - 7 Esselen Street, Hillbrow, Research Centre - Johannesburg**: - **On the 3rd ,4th, and 5th Floor** **Key performance areas**: - Comply with all relevant legislative and...


  • Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To implement pharmaceutical services as per protocols for clinical research studies conducted at Wits RHI research sites **Location**: - **Wits RHI - 7 Esselen Street, Hillbrow, Research Centre - Johannesburg**: - **On the 3rd ,4th, and 5th Floor** **Key performance areas**: - Comply with all relevant legislative and...

  • Laboratory Manager

    1 day ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To plan, organize, direct, control, and coordinate the operations of Wits RHI Ward 21 CRS laboratory, to ensure smooth running and compliance **Location**: - **22 Esselen Street, Hillbrow - Johannesburg** **Key performance areas**: - Plan the activities of the team and delegate tasks to ensure performance objectives are...

  • Research Clinician

    8 hours ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To oversee the clinical and non-clinical aspects of a research project **Location**: - **22 Esselen Street, Hillbrow, Johannesburg** **Key performance areas**: - Conduct clinical assessments, treatment, and/or referral of participants who participate in the study - Record observations in source notes, patient logs, and...

  • Interns X 2

    2 days ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - Day-to-day transcription/translation of qualitative audio, along with qualitative research-related activities including but not limited to administration and quality control **Location**: - **Wits RHI - 7 Esselen Street, Hillbrow, Research Centre - Johannesburg**: - **On the 3rd and 4th Floor** **Key performance...


  • Hillbrow, South Africa MES Full time

    **Job Title** **Chief Financial Officer - CFO** **Reporting Line** **CEO** **Role Purpose** To be the operational lead of all centralised business functions. To define and manage the following functions: - Financial strategy, planning and delivery to ensure financial sustainability and growth. - Risk and compliance standards that are set and delivered...

  • Medical Officer

    6 days ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To recruit, screen, and provide clinical management to participants in clinical trials according to study protocols **Location**: - **Wits RHI - 7 Esselen Street, Hillbrow, Research Centre - Johannesburg**: - **On the 3rd ,4th, and 5th Floor** **Key performance areas**: - Clinical assessment, treatment, and/or referral of...

  • Medical Officer

    1 day ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To recruit, screen, and provide clinical management to participants in clinical trials according to study protocols **Location**: - **Wits RHI - 7 Esselen Street, Hillbrow, Johannesburg**: - **Research Centre**: - **On the 3rd,4th, and 5th Floor** **Key performance areas**: - Clinical assessment, treatment, and/or...


  • Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To design and implement research projects on climate change and health, analyze study findings, and publish scientific articles - Work with multi-disciplinary research groups across Africa, in the EU, UK, and USA - Contribute to projects funded by the Wellcome Trust, NIH, and other donors within the Climate and Health...

  • Medical Officers

    7 days ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To recruit, screen, and provide health care to patients participating in clinical trials according to study protocols - _Maximum 20 working hours per week_ **Location**: - **Wits RHI - 7 Esselen Street, Hillbrow, Research Centre - Johannesburg**: - **On the 3rd ,4th, and 5th Floor** **Key performance areas**: - Screen and...

  • Procurement Officer

    7 days ago


    Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To facilitate the purchasing and receiving of goods bought for Wits RHI projects through the operations department and to develop and maintain effective working relationships with suppliers **Location**: - **7 Esselen Street, Hillbrow, Johannesburg** **Key performance areas**: - Source suppliers according to the...


  • Hillbrow, South Africa AJ Personnel Full time

    **Main purpose of the job**: - To assist the Pharmacist in effectively managing stock, labeling, and dispensing medication **Location**: - **Wits RHI - 7 Esselen Street, Hillbrow, Research Centre - Johannesburg**: - **On the 3rd,4th, and 5th Floor** **Key performance areas**: - Ordering of stock from the main supplier or the pharmaceutical depot -...