Regulatory Manager

2 months ago

Hillbrow, South Africa AJ Personnel Full time

**Main purpose of the job**:

- To monitor and ensure compliance with regulatory and Good Clinical Practice (GCP) requirements within research studies at the Wits RHI Ward 21 Clinical Research Site

**Location**:

- **22 Esselen and Klein Street, Hillbrow, Johannesburg**

**Key performance areas**:

- Strengthen and maintain regulatory systems per SAHPRA, WHREC, WHREC BEC, the sponsor and Dept of Health, ICH, and SA GCP requirements
- Ensure compliance with local and international regulatory bodies and frameworks
- Manage and submit all safety updates, critical events, and protocol deviations per ICH, SA GCP, Ethics Committees and Regulatory Authorities, sponsor and protocol requirements
- Maintain Investigator site files (ISF), electronic Investigator Site Files (eISFs), and all required study essential documents
- Maintain any other required essential documents, e.g., study insurance, participant materials, etc.
- Maintain tracking logs and systems for continued trial/study monitoring and compliance
- Maintain all research staff documents (e.g. CVs, SA GCP, HSP, HPCSA, SANC, SAPC, IATA, GCLP, etc.)
- Ensure all required essential study documents per ICH and SA GCP are audit-ready and compliant
- Support study start-up processes: all regulatory activities to enable site activation
- Support study close-out through to archiving; including e-archiving
- Review systems continuously and recommend improvements to streamline the creation and maintenance of trial documentation; Assist in troubleshooting and rectifying process flow problems in the regulatory process
- Participate and drive SOP management (draft, review, and maintain CRS SOPs)
- Participate and drive CRS quality management: support internal monitoring: regulatory file/ISF reviews per the Clinical Quality Management Plan (CQMP)
- Actively participate in site monitoring/audit/inspection preparations and visits
- Support Training/corrective action for site staff based on QC/QA, internal and external findings
- Review and improve systems to monitor compliance with GCP, to ensure standardization of quality control and quality assurances systems
- Provide training to research staff and new staff/interns, etc. as required
- Effective and efficient staff management

**Required minimum education and training**:

- **Degree in a Health-related field or similar (preferably post-graduate)**:

- **Must have excellent knowledge and understanding of the Local Ethics and Regulatory requirements, as well as those of the FDA, NIH/DAIDS, OHRP, and EMA**

**Required minimum work experience**:

- **Minimum 5 years experience in a clinical trial environment with solid evidence of essential document management and maintenance and/or quality control and quality assurance environment**:

- **Experience with DAIDS/Network trials**:

- **Proficiency and good knowledge with regards to all local and sponsor websites and resources e.g., DAIDS websites, HANC or networks, Wits HREC, WHREC BEC, SAHPRA, DoH, NHRD, PACTR, SANCTR, etc.**

**Desirable additional education, work experience, and personal abilities**:

- Master’s Degree in a health-related field
- Organised and methodical with extreme attention to detail
- Good written and verbal communication skills
- Fluent in English
- Effective self-management, conscientious and precise delivery of work, even when under pressure

**TO APPLY**:

- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- 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.**:

- **AJ Personnel does not have any salary or other information regarding the position.

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