Regulatory Compliance Officer (Wits Ezintsha)

Main purpose of the job:

• To monitor and ensure compliance with regulatory and good clinical research practice requirements within research studies

Location:

• Ezintsha – Parktown office - Johannesburg

Key performance areas:

• Create, establish, and maintain regulatory systems for Ezintsha studies per SAHPRA, WHREC, sponsor, and DOH requirements
• Provide expert guidance on the requirements of local and international regulatory bodies and frameworks, and support the department to comply with those requirements
• Review systems and recommend improvements to streamline the creation and maintenance of trial documentation
• Support drafting and submissions of technical reports to IRBs and IECs, SAHPRA, and sponsors as needed
• Actively participate in the submission of research protocols
• Review and advise on improvements and standardization of quality control and assurance systems with respect to improved compliance with regulatory frameworks
• Update site delegation logs when new staff join
• Ensure adequate training is completed by the new staff members and training logs completed
• Ensure staff adhere to responsibilities defined in site delegation logs per qualifications and training
• Ensure that all SOPs have been read and signed by all staff. When SOPs are revised, circulate new signage sheets for completion on review
• To prepare, review, and revise standard operating procedures per study-specific needs
• Review and ensure that the study has all essential regulatory documentation
• Assist sponsors/monitors before, during, and after the monitoring visits
• File study screening and enrolment log in the investigator site file
• Ensure study is compliant with GCP/Ethics by ensuring that written Informed Consent is obtained prior to participation in the study and according to study SOPs
• Assist in the completion of corrective action for both internal and external monitoring reviews
• 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

Required minimum education and training:

• 3-year diploma or degree in a health-related field

Required minimum work experience:

• Minimum 2 years relevant work experience within a clinical research environment

Desirable additional education, work experience, and personal abilities:

• Experience in pharmaceutical or quality environment would be an added advantage
• Understanding of the research language, detailed knowledge, and understanding of the relevant studies and SOPs, knowledge of clinical research documentation
• Detailed knowledge of regulatory application and approval processes
• Computer literate with the 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
• 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.
• 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.
• The closing date for all applications: 16 March 2022.
• 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.
• 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: Our Client, WHC - Ezintsha, maintains mandatory Covid-19 requirements, and as such only Covid-19 vaccinated incumbents will be considered for positions.

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.