SUMMARY:
A Regulatory Administrator (Fixed Term Contract) vacancy is available at our Client, Wits Health Consortium’s Wits Reproductive Health and HIV Institute (Wits RHI) in Hillbrow, Johannesburg - Gauteng.

POSITION INFO:

Background

The Wits Reproductive Health and HIV Institute (Wits RHI) is a renowned African-led research institute that seeks solutions to Africa’s health challenges.

It is located within the University of the Witwatersrand and addresses some of the greatest public health concerns affecting our region, including HIV and its related problems, sexual and reproductive health, and vaccinology. This is done through pioneering, multi-disciplinary research; responsive technical support and innovation in health services; and evidence-based policy development and advocacy with national, regional, and global stakeholders.

Main purpose of the job 

• To assist with ensuring compliance with regulatory and good clinical research practice requirements within research studies at Wits RHI Shandukani Research Centre 

Location

•  Wits RHI - Shandukani Research Centre

Key performance areas

• Maintain regulatory systems for Wits RHI Shandukani studies per SAHPRA, WHREC, sponsor, GCP, and DOH DRC requirements
• Compiling of documents for initial Submissions for IMPAACT & Pharma Studies: Ethics, SAHPRA 
• Following up of approvals from Gauteng Research District, COJ, CEOs, Clinic Managers
• Completion and updating of online applications on NHRD, NHREC, SANCTR, and other applicable online systems
• Updating tracking logs for all submissions, approvals
• Six-Monthly Progress Reports: Ethics, SAHPRA, DRC tracking all events for the last six months and sending submission packs to sites
• Retain current research staff CVs, GCP, MPS, HPCSA, SAPC, SANC certificates                                 
• Participate in monitoring visits, internal (Sponsor) and external regulatory (FDA and EMA) inspections    
• Review and ensure that the study has all essential regulatory documentation
• Assist sponsors/monitors before, during, and after monitoring visits
• 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

• Diploma or Degree in a health-related field

Desirable additional education, work experience, and personal abilities

• Knowledge of Good Clinical Practice
• Understanding of the research language, knowledge and understanding of the relevant studies and SOP’s, knowledge of clinical research documentation
• Computer literate with the ability to create or work with databases/excel logs
• 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, attention to detail, and problem-solving skills
• Conscientious and precise delivery of work even when under pressure
• Effective self-management, resourcefulness, and initiative to solve problems

Required minimum work experience

• Minimum 2 years relevant work experience within a clinical research environment (preferably in the regulatory department)

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
• 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 is 10 June 2021.
• 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.
• 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.

Please note that 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. 

NB! This job is now closed. You can apply for other jobs by uploading your CV.