Regulatory Compliance Officer

2 weeks ago

Hillbrow, South Africa AJ Personnel Full time

**Main purpose of the job**:

- To monitor and ensure compliance with regulatory and good clinical research practice requirements within research studies within the Research Centre in Johannesburg

**Location**:

- **Wits RHI - 7 Esselen Street, Hillbrow, Research Centre - Johannesburg**:

- **On the 3rd ,4th, and 5thFloor**

**Key performance areas**:

- Create, establish and maintain regulatory systems for Wits RHI studies per SAHPRA, HREC, sponsor, and DOH requirements. Print and file regulatory documentation
- Work with the Regulatory Oversight Group (ROG) and Research Review Committee (RRC) as needed and provide expert guidance on the requirements of local and international regulatory bodies and frameworks and support the department to comply with those requirements
- Track annual recertification submissions to HREC
- Review systems and recommend improvements to streamline the creation and maintenance of trial documentation and review and advise on improvements and standardization of quality control and assurance systems with respect to improved compliance with regulatory frameworks
- Actively participate in the submission of research protocols and where appropriate assist in writing funding proposals for improvements in monitoring, evaluation, and quality control of data
- Ensure site delegation logs are updated when there are staffing changes
- Ensure adequate training is completed by staff members 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 are revised circulate new signage sheets for completion on review
- Prepare site-informed consent forms and 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
- Perform duties per study Delegation of Authority Logs
- Ensure participants are enrolled per defined eligibility criteria
- Provide training to staff in areas of expertise to reduce repetitive errors noted during the study file review
- Assist in the completion of corrective action for both internal and external monitoring reviews
- Ensure the site is well prepared for internal and external lab, pharmacy, clinical, social science, and community monitoring reviews
- Ensure documentation is adequate on study-specific procedures
- Assess compliance to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and Regulatory Essential Documents per sponsor requirements and determine the accuracy of research records
- 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 of 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**

**Required minimum work experience**:

- **Minimum 3 years of relevant work experience within a Clinical Research environment in Regulatory Compliance**

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

- A postgraduate degree in Quality Management would be an added advantage
- Understanding of the research language, detailed 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
- 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.
- _AJ Personnel is fully POPIA Compliant._
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.

**Please note**:

- **Our Client, WHC - RHI, maintains mandatory Covid-19 requirements, and as such only Covid-19 vaccinated incumbents will be considered for positions.**:

- WHC, in accordance with its 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.
- AJ Personnel is only responsible for advertising the advertisement on behalf of their client Wits He

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