Internal Monitor (Wits PHRU) - - Soweto

Main purpose of the job:

To assist with the performance of clinical trial-related duties ensuring protocol adherence, legibility, completeness, and consistency of data by being responsible for internal monitoring, validation, and auditing of participants’ source documents, CRF files, and site files
To perform quality assurance activities in accordance with the Site’s Quality Management Plan, Sponsor regulatory requirements, and ICH GCP requirements
Case Report Form completion and adherence regarding source documentation as in accordance with Good Clinical Practice

Location:

PHRU – Chris Hani Baragwanath Hospital, Soweto - Johannesburg

Key performance areas:

Review and verify CRFs and source documentation to ensure accuracy, completeness, and compliance with applicable regulations
Identify trends of inconsistencies and deviations from the requirements and regulations
Generate monthly monitoring reports that included a quantitative and qualitative review of source documentation and CRFs monitored
Document findings relating to the monitoring of CRFs and source documents and disseminate these findings to the appropriate clinical staff
Assist staff with GCP and audit-compliant resolution of all monitoring findings
Ensure that there is adequate documentation that findings have been resolved appropriately and timeously
Assist in reviewing specified records prior to site monitoring visits, audits, or inspections
Review Site Monitoring Reports generated by monitors to assist in identifying trends and errors in completing CRFs and source documents and apply this knowledge to improve subsequent monitoring
Provide training on the broad trends identified during internal and external monitoring
Create, amend, and provide staff with tools: i.e. checklist and tracking logs to ensure the prevention of errors
Complete the Clinical Quality Management Plan (CQMP) document in consultation with management taking into account donor requirements and specifications
Establish through the CQMP clearly defined Quality Control Procedures and policies for the entire team
Ensure that the CQMP is adhered to
Ensure site readiness for new protocols
Develop tools and source documents to ensure protocols are adhered to and a smooth collection of required data
Review site investigator files to ensure all relevant documents are filed and maintained accordingly
Ensure that all requirements for study activation have been met, documented, and filed appropriately
Ensure that all required training is completed and documented

Required minimum education and training:

Minimum of a Bachelor's Degree, in a science or health science discipline
CRA (Clinical Research Associate) training would be advantageous

Required minimum work experience:

At least 1 year of experience within the research field

Desirable additional education, work experience, and personal abilities:

Meticulous attention to detail
Logical thinker with an ability to work independently within a team environment
Proactive, enthusiastic with good time management skills
Ability to apply consistent adherence to intentional research and GCP practices
Intermediate Computer Skills
The ability to establish and maintain effective working relationships with internal stakeholders
Effective Written and Verbal communication at all levels
Excellent reporting skills
Able to work under pressure in a high-cognitive environment

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: 17 April 2024.
Note AJ Personnel is fully POPI compliant.
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.
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.
AJ Personnel does not have any salary or other information regarding the position.

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