Internal Monitor

Type: Permanent

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

Closing Date:

• 06 April 2023

Submit detailed CV to: vacancy5@wrhi.ac.za

Advert reference number: UM 17-2023

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.

Key performance areas:

Review and verify CRF’s and source documentation to ensure accuracy, 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 QA
  Reports and disseminate 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.
• Review Site Monitoring Reports generated by monitors to assist in identifying trends and errors in
  completing CRF’s and source documents and apply this knowledge to improve subsequent monitoring.
• 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 utilisation 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 organisation.
• Promote harmony, teamwork and sharing of information.
• Actively and consistently maintain high standards of professionalism in all aspects of personal
  presentation and delivery.
• Apply knowledge of the organisational systems, structures, policies, and procedures to achieve results.
• 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 organisation’s core values.
• Maintain a positive attitude.
• Respond openly to feedback.
• Take ownership for driving own career development.

Required minimum education and training

• Degree / Diploma in a medical or scientific field.

Desirable additional education, work experience and personal abilities

• Preferably Human subjects’ protection training.
• 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 organisational skills with meticulous attention to detail.
• Sound knowledge of good clinical practice.
• Ability to work independently in a team and be pro-active.
• Computer skills in Microsoft Office (Excel on intermediate level).

Required minimum work experience

• Minimum 2 years’ experience of on-site monitoring/QC in a medical discipline

Should you be interested in applying for this vacancy, please send an email to vacancy5@wrhi.ac.za. The
subject heading of the email must read UM 17-2023 and the job title of position applying for. Please include the
following documentation:

• A cover letter (maximum one page) that clearly states which vacancy you are applying for
• A detailed CV