Administrator (Ethics and Regulatory) Wits VIDA

Main purpose of the job:

• To coordinate regulatory operations and support the VIDA ethics and regulatory department with its core functions such as submissions, maintenance, and administration of regulatory and essential documents, in accordance with study protocols, Good Clinical Practice, sponsor requirements, and VIDA standards

Location:

• Vaccines & Infectious Diseases Analytics Research Unit, Wits Learning Centre Building (Nurses Residence), Chris Hani Baragwanath Academic Hospital, and other VIDA sites - Gauteng

Key performance areas:

Initial submissions to conduct research studies and clinical trials

• Ensuring all submission documents and correspondence are maintained electronically, and copies made for the regulatory and site files within one day of receipt
• Maintain and update trackers daily – EC/Regulatory Body Correspondence, Protocol Amendments, Informed Consent Forms, Letters of Amendment, Clarification Memos; etc. Timeline: all tracking logs should be maintained in real-time
• Prepare all application content for applicable regulatory or ethics bodies; create or review documents for accuracy and completion
• Submit applications in a timeous and accurate manner to all applicable bodies (this includes amongst others initial protocol and amendment applications, re-certifications, new investigator applications, and all information updates including package inserts/investigator brochures, DSMB reports, and safety or progress reports)

Maintenance of research applications and ongoing regulatory support activities

• Provide support to and include other, eg. satellite sites in SAHPRA applications, as required
• Submission of the following documentation to SAHPRA, Wits EC as required: annual study recertification, bi-annual study progress reports, protocol amendments, informed consents version changes, clarification memos, change and addition of investigators, study insurances, and other required maintenance activities
• Liaison with monitors and other stakeholders as required to support effective regulatory management

Compliance and general regulatory and filing support

• Timely and efficient submission of the following documentation to SAHPRA, Wits EC as well as distributing to the clinical trial staff as required: IND Safety letters, SUSARs, Safety Memos, Comprehensive Safety Memos
• Ensure timely submission (as per Sponsor requirements) of annual recertification to HREC, Prepare and submit
• Implement timely and regular follow-up of submissions to minimize delays in approvals
• Support and prepare for audits
• Assist to ensure all staff are GCP certified and track all insurances, memberships, etc as required

Required minimum education and training:

• Tertiary qualification preferred

Required minimum work experience:

• Minimum 2 years experience in regulatory/ethics role (demonstrable administration organization experience)

Desirable additional education, work experience, and personal abilities:

• GCP (Good Clinical Practice)
• Basic computer literacy
• Ability to work extended hours
• Meticulous
• Understanding of research environment
• Customer focus and service delivery
• Communication
• Teamwork

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: 22 June 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.

Please note:

• Our Client, WHC - VIDA, 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.