Internal Monitor

2 weeks ago

Soweto, South Africa AJ Personnel Full time

**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
- 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
- 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 take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- 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.**:

- **AJ Personnel does not have any salary or other information regarding the position.

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