Main purpose of the job:
• To file, retrieve and maintain Regulatory documents
• To ensure Regulatory Site Files are up to date and/or Audit ready
• To assist with document submissions to South African Health Products Regulatory Authority, WITS Ethics Committee, National Health Research Database, and Helen Joseph Hospital
Helen Joseph Hospital – Perth Road, Westdene, Johannesburg
Key performance areas:
• Filling of Essential Documents in the Site Master files
• Copying, scanning, and saving documents on Regulatory R: Drive in study-specific folders
• Uploading study regulatory documents onto Veeva Vault as required by DAIDS for remote monitoring
• Create/Set up study-specific Regulatory Files and Pharmacy Files
• Prepare and maintain the content of the regulatory files for each clinical research project
• Collate updated Investigator and site staff documents
• Responsible for collation of Initial submission packs to SAHPRA and Wits EC
• Assist with preparation and completion of FDA1572, Investigator of Record, Financial Disclosure forms
• Assist with uploading relevant documents onto the DAIDS Protocol Registration system
• Updating the Regulatory Submission Tracker on a monthly basis
• Safety Memo collation and filing in the regulatory drive of these reports, notifications to Ethics and SAHPRA, AoR of notifications on return to the regulatory office
• Keeping track of Safety reports read by staff on Veeva Vault
• Assist the Regulatory Manager with timely submissions of relevant documentation to the SAHPRA, Wits Ethics Committees, and to Helen Joseph Hospital Superintendent
• Assist the Regulatory Manager with communication and correspondence with other sites where combined submissions are done
• Provide support to Regulatory Manager regarding Commercial studies and Investigator Initiated research, as required
Required minimum education and training:
Computer Literacy skills
Required minimum work experience:
1 year of work experience in an administrative environment within a research environment
Computer literate in MS Word, MS Outlook, and MS Excel
Desirable additional education, work experience, and personal abilities:
• Clinical trial background and knowledge
• Working knowledge of Access Database
• Ability to work under pressure
• Time Management
• Attention to Detail
• Up-to-date GCP certificate
• 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:
14 September 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.
Our Client, WHC – CHRU, maintains mandatory Covid-19 requirements, and as such only Covid-19 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.