Regulatory & Compliance Officer (Wits RHi)

**Main purpose of the job**:

- To monitor and ensure compliance with regulatory and good clinical research practice requirements within research studies

**Location**:

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

- **On the 3rd and 4th Floor**

**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 IRBs, MCC, and sponsors as needed
- 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
- 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 is 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
- Revise, and circulate new signage sheets for completion of the 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 the 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 the site is well prepared for internal and external lab, pharmacy, clinical, and community monitoring reviews

**Required minimum education and training**:

- **3-year diploma or degree in a health-related field**

**Required minimum work experience**:

- **Minimum 2 years of relevant work experience within a clinical research environment**

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