Job Description

Main purpose of the job:

• Ensure QA and QC activities performed effectively across studies
• Where trends identified, coordinate relevant staff training

Location:

• 22 Esselen Street, Hillbrow, Johannesburg

Key performance areas:

• Determine through critical review the accuracy of research records
• Ensure errors on CRF's and relevant databases are corrected, initialed and dated by the authorized signatory
• Ensure completion of corrective action of internal and external QC reports
• Ensure site is well prepared for external lab, clinical, social science and community monitoring reviews
• Assist in completion of corrective action for monitoring reviews
• Assist/ensure completion of corrective action for internal monitoring reviews in a timely manner
• Compile QA/QC report/s on findings for site management team
• Support Regulatory/Data team with periodic quality assurance activities
• Review and ensure essential regulatory documentation available and up to date across all studies
• Assist with the review and revision of standard operating procedures per study specific needs as needed
• Assess staff awareness and compliance to Good Clinical Practice (GCP), Protocol requirements, Standard Operating Procedures (SOPs) and Regulatory Essential Documents per sponsor requirements
• Coordinate staff training (and retraining) where error trends are identified
• Take ownership and accountability for tasks and demonstrates effective self-management
• Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
• Maintain a positive attitude and respond openly to feedback.
• Take ownership for driving own career development by participating in ongoing training and development activities such as conferences, workshops, etc.

Required minimum education and training:

• 3-year Diploma or Degree in a health-related field

Required minimum work experience:

• Minimum 1-2 years relevant work experience within a clinical research environment in Quality Control and Quality Assurance

Desirable additional education, work experience and personal abilities:

• A post graduate degree would be an added advantage
• Extensive understanding of the research language, detailed knowledge and understanding of the relevant studies and SOPs, knowledge of clinical research documentation
• Computer literate with ability to create or work with databases
• Fluent in English, fluency in one of the other official SA languages particularly Zulu or Sesotho would be an added advantage
• Good written and verbal communication skills
• Strategic thinking and problem-solving skills.
• Conscientious and precise delivery of work even when under pressure
• Effective self-management, resourcefulness and initiative to solve problems
• Excellent communication and presentation skills

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 and complete your registration on Ditto Hire (our application tracking system) to enable and protect you as a candidate to accept the new POPIA terms and conditions. This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL. However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market.
• 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 September 2024.
• 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.

AJ Personnel