Internal Monitor

2 weeks 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 requirements

**Location**:

- **Shandukani Research Centre, Wits RHI, Hillbrow - 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 listed above
- Document findings relating to the monitoring of CRFs and source documents by completing QA Reports and disseminating these findings to the appropriate clinical staff
- Ensure that QA Reports are returned timeously and include adequate documentation that findings have been resolved appropriately
- Assist in reviewing specified records prior to monitoring visits, site audits by sponsors, or inspections by other regulatory bodies
- Keep an updated record of the number of records monitored, including details of PID numbers and visits reviewed
- Provide monthly monitoring statistics to reflect the percentage of the total number of records reviewed for a particular protocol
- Develop tools and source documents to ensure protocols are adhered to and the smooth collection of required data
- Identify trends in errors in CRF completion and conduct training for staff on corrective and preventative actions
- Provide feedback during site staff meetings on relevant QA and QC issues
- Training and mentoring in the course of everyday duties, providing necessary feedback to all departments and management as needed
- Assist in the development and review of Site Standard Operating Procedures
- 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
- Actively and consistently maintain high standards of professionalism in all aspects of personal presentation and delivery
- Follow through to ensure that productivity standards are consistently and accurately maintained
- Provide appropriate resolution for tasks or deadlines not met
- Support and drive the organization’s core values
- Maintain a positive attitude
- Respond openly to feedback
- Take ownership of driving your own career development

**Required minimum education and training**:

- **Degree/Diploma in a Medical or Scientific field**

**Required minimum work experience**:

- **Minimum 2 years experience in on-site monitoring/QC in a Medical discipline**

**Desirable additional education, work experience, and personal abilities**:

- Clinical Research Associate (CRA)training
- Registration with the South African Clinical Research Association (SACRA) would be advantageous
- Accredited ICH/GCP course and Basic HIV training course
- Good administrative and organizational skills with meticulous attention to detail
- Sound knowledge of the good clinical practice
- Ability to work independently in a team and be pro-active
- Computer skills in Microsoft Office (Excel on an intermediate level)

**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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