To monitor and ensure compliance with regulatory and good clinical research practice requirements within research studies within the Shandukani Research Centre
Location:
7 Esselen Street, Hillbrow, Johannesburg
Key performance areas:
Maintain a positive attitude and respond openly to feedback
Maintain regulatory systems for Wits RHI Shandukani studies per SAHPRA, WHREC, sponsor, and DOH DRC requirements
Support in drafting submissions of technical reports to IRBs, SAHPRA, and sponsors as needed
Initial Submissions for IMPAACT & Pharma Studies: Ethics, SAHPRA preparation, submissions, communication, and follow-up
Recruitment Approvals: Gauteng Research District, COJ, CEOs, Clinic Managers' submissions and approvals on the NHRD
Amendments, LOA, CM: Ethics, SAHPRA preparation, submissions, communication, follow up and updating tracking log
Annual Recertification: Ethics, preparations, submissions and follow up
Six-Monthly Progress Reports: Ethics, SAHPRA, and DRC tracking all events for the last six months (bi-weekly reports for studies for public health outbreaks)
Safety Updates: Ethics and SAHPRA line listings submissions and updating tracking log
Retain current research staff CVs, GCP, MPS, HPCSA, SAPC, and SANC Certificates
Informed Consent review
Participate in monitoring visits, internal (Sponsor) and external regulatory (FDA and EMA) inspections
Review systems and recommend improvements to streamline the creation and maintenance of trial documentation i.e., Project Management
Guide on the requirements of local and international regulatory bodies and frameworks, and support the department to comply with those requirements i.e., Community & Stakeholders Workshop
Review and ensure that the study has all essential regulatory documentation
Assist sponsors/monitors before, during, and after monitoring visits
Study insurance renewals, liaising with the sponsor regarding approval of insurance funds
Take ownership and accountability for tasks and demonstrate 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 of driving your 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
Required minimum work experience:
Minimum 3 years of relevant work experience within a Clinical Research Environment (if possible, in the Regulatory Compliance Department)
Desirable additional education, work experience, and personal abilities:
Understanding of the research language, detailed knowledge and understanding of the relevant studies and SOPs, knowledge of clinical research documentation
Detailed knowledge of regulatory application and approval processes
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 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
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: 10 January 2024.
Note AJ Personnel is fully POPI compliant.
Note WHC, in accordance with their 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.
Please note:
AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
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.
AJ Personnel does not have any salary or other information regarding the position.