Internal Monitors X 2 - Hillbrow, South Africa - AJ Personnel

AJ Personnel

Verified Company

Hillbrow, South Africa

2 weeks ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

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:

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Shandukani Research Centre, Wits RHI, Hillbrow

Johannesburg

Key performance areas:

Review and verify CRFs and source documentation to ensure accuracy and 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:

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Degree/Diploma in a Medical or Scientific field

Required minimum work experience:

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Minimum 2 years experience of 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
An ability to work independently in a team and be proactive
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.

- _AJ Personnel is fully POPIA Compliant._

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

Please note:

-
Our Client, WHC
RHI, maintains mandatory Covid19 requirements, and as such only Covid19 vaccinated incumbents will be considered for positions
:

WHC, in accordance with its 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.
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.