Job Description

Job Summary

Main purpose of the job:

• To assist with ensuring compliance with regulatory and good clinical research practice requirements within research studies at the Unit

Location:

• ILTBRU - Jose Pearson TB Hospital, Gqeberha (Port Elizabeth)

Key performance areas:

• Maintain regulatory systems for ILTBRU studies per SAHPRA, WHREC, sponsor, GCP, and DOH requirements
• Compiling of documents for initial Submissions for Studies: Ethics, SAHPRA
• Following up on approvals from Eastern Cape Research District, CEOs, Clinic Managers
• Completion and updating of online applications on NHRD, NHREC, SANCTR, and other applicable online systems
• Updating tracking logs for all submissions, approvals
• Six-Monthly Progress Reports: Ethics, SAHPRA, DRC tracking all events for the last six months and sending submission packs to sites
• Retain current research staff CVs, GCP, MPS, HPCSA, SAPC, and SANC Certificates
• Participate in monitoring visits, internal (Sponsor) and external regulatory (FDA and EMA) inspections
• Review and ensure that the study has all essential regulatory documentation
• Assist sponsors/monitors before, during, and after monitoring visits
• Assist in troubleshooting and rectifying process flow problems in the regulatory process
• Stationary - checking and completing stationery orders as required
• Ensure all interaction (Both internal and external stakeholders) is of the highest professional level; E.g. Respond to emails/queries within two days
• Build and maintain authentic relationships with all stakeholders ensuring that all interactions are professional
• Effectively manage work processes in order to maintain high levels of productivity
• Establish and maintain a relationship of trust and respect with all stakeholders
• Comply with Good Clinical Practice (GCP), Protocol Standard Operating Procedures (SOP)
• Review regulatory files regularly
• Ensure completion of corrective action of internal and external QC reports and monitoring reviews
• Assist with staff training (and retraining) was required
• Ensure all interaction (Both internal and external stakeholders) is of the highest professional level; E.g. Respond to emails/queries within 2 days
• Build and maintain authentic relationships with all stakeholders ensuring that all interactions are professional
• Effectively manage work processes in order to maintain high levels of productivity
• Establish and maintain a relationship of trust and respect with all stakeholders

Required minimum education and training:

• Diploma or Degree in a Health-related field

Required minimum work experience and abilities:

• Minimum 2- years of relevant work experience within a Clinical Research environment (preferably in the Regulatory Department)

Desirable additional education, work experience, and personal abilities:

• Knowledge of Good Clinical Practice
• Understanding of the research language, knowledge, and understanding of the relevant studies and SOPs, knowledge of clinical research documentation
• 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 isiXhosa would be an added advantage
• Good written and verbal communication skills
• Strategic thinking, attention to detail, and problem-solving skills
• Conscientious and precise delivery of work even when under pressure
• Effective self-management, resourcefulness, and initiative to solve problems

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: 21 November 2023.
• 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.

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