SUMMARY:
A Regulatory Compliance Officer vacancy is available at our Client, Wits Health Consortium's Reproductive Health and HIV Institute (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 monitor and ensure compliance with regulatory and good clinical research practice requirements within research studies

Location

• Hillbrow – Research Centre

Key performance areas

• Create, establish and maintain regulatory systems for Wits RHI studies per MCC, 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 IRB’s, MCC and sponsors as needed
• Actively participate in the submission of research protocols and where appropriate assist in writing funding proposals for improvements of monitoring, evaluation and quality control of data
• 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 completed by a new staff member 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
• 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 review
• Ensure participants are enrolled per defined eligibility criteria
• Complete and maintain study screening and enrolment log including the assigning of Participant Identifiers (PTIDs)
• Review and improve systems to monitor compliance with GCP and recommend interventions to identify, evaluate and rectify problems in Case Report Forms (CRF) and study-specific document completion
• Review and advise on improvements and standardization of quality control and assurance systems with respect to improved compliance with regulatory frameworks
• Provide training to staff and students in areas of expertise to reduce repetitive errors noted during the study file review
• 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
• Ensure errors on Source documents are corrected as per GCP
• Compile QA/QC report/s on findings as required
• Assist in the completion of corrective action for both internal and external monitoring reviews
• Ensure site is well prepared for internal and external lab, pharmacy, clinical community monitoring and 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
• Take ownership for driving your own career development by participating in ongoing training and development activities such as conferences, workshops, etc.

Required minimum education and training

• 3-year Diploma or Degree in a health-related field

Desirable additional education, work experience and personal abilities

• A post-graduate degree in Quality Management would be an added advantage
• Understanding of the research language, detailed knowledge and understanding of the relevant studies and SOP’s, 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 
• Good written and verbal communication skills
• 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

Required minimum work experience

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

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 06 April 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 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. 

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