Administrator (Ethics and Regulatory) VIDA

SUMMARY:
An Administrator (Ethics and Regulatory) vacancy is available at our Client, Wits Health Consortium's Vaccines and Infectious Diseases Analytics Research Unit (VIDA) in Soweto, Johannesburg - Gauteng.

POSITION INFO:

Background

The Vaccines and Infectious Diseases Analytics (VIDA) Research Unit of the University of the Witwatersrand, formerly RMPRU (Respiratory and Meningeal Pathogens Research Unit) has for over 20 years conducted numerous studies to assess the burden of and to prevent vaccine-preventable diseases (VPD).

Current studies and projects include infant rotavirus and BCG trials, immunizing pregnant women to protect their infants against disease (including influenza, Group B streptococcus, and respiratory syncytial virus), and the Child Health and Mortality Prevention Surveillance (CHAMPS) initiatives.

In 2020, VIDA commenced two international trials on COVID-19 vaccines amongst several other COVID-19 studies. World Health Organization position papers directly refer to the work conducted by RMPRU and have used such data generated to inform policy and recommendations for vaccine implementation globally and here in South Africa. 

By combining clinical, microbiological, and epidemiological expertise in an African setting, the unit has made significant contributions in vaccine development against the leading respiratory and enteric pathogens contributing to under-5 childhood morbidity and mortality in Africa and other low and middle-income countries.

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

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

Key performance areas

Initial submissions to conduct clinical trials

1. Ensuring all submission documents and correspondence are maintained electronically, and copies made for the regulatory and site files within one day of receipt
2. 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
3. Create or review documents for accuracy and completion
4. 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, all information updates including package inserts/investigator brochures, DSMB reports and safety or progress reports)

Maintenance of research applications

1. Provide support and include other, eg. satellite sites in SAHPRA applications, as required
2. 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

Regulatory Compliance

1. 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
2. Ensure timely submission (as per Sponsor requirements) of annual recertification to HREC, Prepare and submit
3. Implement timely and regular follow-up of submissions to minimize delays in approvals

Required minimum education and training

• Grade 12

Required minimum work experience

• Minimum 2 years experience in regulatory/ethics role

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 and 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
• 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 07 May 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.