SUMMARY:
A Quality Assurance Manager vacancy is available at our Client, Wits Health Consortium’s Wits Reproductive Health and HIV Institute (Wits RHI) in Hillbrow, Johannesburg - Gauteng.
POSITION INFO:
Background
The Wits Reproductive Health and HIV Institute (Wits RHI) is a renowned African-led research institute that seeks solutions to Africa’s health challenges.
It is located within the University of the Witwatersrand and addresses some of the greatest public health concerns affecting our region, including HIV and its related problems, sexual and reproductive health, and vaccinology. This is done through pioneering, multi-disciplinary research; responsive technical support and innovation in health services; and evidence-based policy development and advocacy with national, regional, and global stakeholders.
The main purpose of the job
- To coordinate the quality assurance (QA), quality control (QC), data processing and data management activities of research projects such as developing standard operating procedures, overseeing/coordinating QA/QC activities, data capturing and providing analysis output and training
Location
- Wits RHI – Research Centre, Hillbrow
Key performance areas
Quality Control
- 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, initialled and dated by the authorised 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), programme manager (PM), or study coordinator (SC) as applicable
•Quality Assurance
- 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’s and pregnancies)
- Determine, through critical review, the accuracy of research records
- Compile QA/QC reports or findings for the site management team
- Assist in 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
Regulatory
- 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
Internal monitoring and validation of clinical data
- Review clinical trial data and ensure compliance with protocol requirements
- Evaluate the quality and integrity of the source document and CRF’s 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
• External monitoring audit preparation
- 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 completion of corrective action for external monitoring reviews/audits and inspections
• Liaise and communicate with relevant stakeholders on issues related to the trial protocols and quality of data
- Attend and contribute to protocol-specific and organizational meetings
- Provide monthly updates of 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
• Annual review of CRS SOPS, Quality Management Plans (QMPs) and other documents
- Update relevant CRS documentation when required
- Initiate and compile new CRS documents as required
• Data Management
- 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 assure 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 data management team at meetings as required
• Staff Management
- Attend to all staffing requirements and administration
- Supervise and manage the duties of subordinates to ensure optimal staff utilisation and maintenance of sound labour 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 organisation
- Promote harmony, teamwork and sharing of information
Effective self-management and performance ownership
- Take ownership and accountability for tasks and demonstrate effective self-management
- Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
- Maintain a positive attitude and respond openly to feedback
- Take ownership for driving own career development by participating in ongoing training and development activities such as forums, conferences, policy setting workshops, etc.
Required minimum education and training
- 3-year diploma or bachelor’s degree in a medical, scientific or health-related field
- A qualification in Quality Management would be advantageous as would a diploma in Information Technology or Statistics (or equivalent)/ Certification in Data Analysis programmes (STATA, SAS, SQL and Access)
Desirable additional education, work experience, and personal abilities
- Human subjects’ protection and ICH/GCP training/certification is desirable
- Understanding of the research language, detailed knowledge and understanding of the relevant studies and standard operating procedures (SOPs), knowledge of clinical research documentation and good clinical practice
- Good administrative and organizational skills with meticulous attention to detail
- Computer literate, able to work with Microsoft Word, Excel and PowerPoint and have the ability to create or work with relevant data sets
- Good written and verbal communication skills (specifically a good command of English - read, write, speak and understanding) and presentation skills are required. Fluency in isiZulu would be an added advantage
- Strategic thinking and problem-solving skills
- Conscientious and precise delivery of work even when under pressure
- Effective self-management. resourcefulness and initiative to solve problems
- An ability to work independently in a team and be proactive
Required minimum work experience
- Minimum five years’ experience in Clinical Research with experience in quality control, quality assurance and data management, preferably two years’ experience as a Clinical Research Associate/Internal Monitor
- Minimum of one year experience in a management position
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
- 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 is 20 August 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.
- In accordance with our Employment Equity goals and plan, preference will be given to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.
Please note that AJ PERSONNEL is only responsible for advertising the advertisement on behalf of their client Wits Health Consortium.
AJ Personnel does not have any salary or other information regarding the position.
NB! This job is now closed. You can apply for other jobs by uploading your CV.
