An Internal Monitor vacancy is available at our Client, Wits Health Consortium’s Reproductive Health and HIV Institute (RHI) in Hillbrow, Johannesburg – Gauteng.
BackgroundThe 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.
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 and Sponsor regulatory requirements and ICH GCP requirements
Location
- Wits RHI- Shandukani Research Centre – Hillbrow – Johannesburg
Key performance areas
- Review and verify CRF’s and source documentation to ensure accuracy and completeness and compliance with applicable regulations
- Identify trends of inconsistencies and deviations to the requirements and regulations listed above
- Document findings relating to the monitoring of CRF’s and source documents by completing SDV forms and disseminate these findings to the appropriate clinical staff
- Ensure that SDV forms are returned timeously and include adequate documentation that findings have been resolved appropriately
- Assist in reviewing specified records prior to site audits by DAIDS contract monitors or inspections by other regulatory bodies
- Review Quarterly Site Monitoring Reports generated by DAIDS contract monitors to assist in identifying trends and errors in completing CRF’s and source documents and apply this knowledge to improve subsequent monitoring
- Generate monthly monitoring reports that included a quantitative and qualitative review of source documentation and CRF’s monitored
- Ensure site readiness for new protocols
- Develop tools and source documents to ensure protocols are adhered to and smooth collection of required data
- Collate reports for next financial year’s study visits
- Draft a summary of costs per patient for each study
- Review new and updated budgets and/or PSTO’s for all studies
- Submit financial forecast reports to programme manager
- Attend to all staffing requirements and administration
- Supervise and manage the duties of subordinates to ensure optimal staff utilization 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 organization
Required minimum education and training
- Minimum Diploma or Certificate qualification in the medical or scientific field
Desirable additional education, work experience and personal abilities
- Preferably Human subjects’ protection training, preferably CRA (Clinical Research Associate) training
- Registration with the South African Clinical Research Association (SACRA) would be advantageous Minimum complete an accredited ICH/GCP course and Basic HIV training course
- Good administrative and organizational skills with meticulous attention to detail
- Sound knowledge of good clinical practice
- An ability to work independently in a team and be pro-active
- Computer skills in Microsoft Office (Excel on an intermediate level)
Required minimum work experience
- Minimum 2 years experience of on-site monitoring in a medical discipline
TO APPLY
- Only if you do meet the minimum job requirements and experienceas 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 22 March 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 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.
Employer & Job Benefits:
- Medical Aid and Provident Fund