Regulatory and Compliance Officer

**Main purpose of the job**:

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

**Location**:

- **PHRU - Tshepong Hospital, Matlosana, Klerksdorp**

**Key performance areas**:

- Maintain regulatory systems for PHRU-Matlosana studies per SAHPRA, WHREC, sponsor and DOH, and District Research Committee (DRC) requirements
- Support in drafting submissions of technical reports to IRBs, SAHPRA, and sponsors as needed
- Initial Submissions for all studies: Ethics, SAHPRA preparation, submissions, communication, and follow-up
- 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
- Real-time Informed Consent Quality Control Review
- Participate in monitoring visits, internal (Sponsor) and external regulatory inspections
- Review systems and recommend improvements to streamline the creation and maintenance of trial documentation i.e. Essential Document Maintenance
- Guide 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
- 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 concerning improved compliance with regulatory frameworks
- Champion and Plan training to staff and students in areas of expertise to reduce repetitive errors noted during study file review
- Ensure the study is compliant with GCP/Ethics by ensuring that written Informed Consent is obtained before 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
- 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 Health Sciences**:

- **Registered with the appropriate regulatory authority**

**Required minimum work experience**:

- **At least 2 years of experience in a Clinical Research Environment**:

- **Experience in Regulatory Submissions and Maintenance of Essential Documents would be advantageous**

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

- Require good organizational, administrative, and analytical skills
- Best Regulatory Administration
- Effective Self-management
- Regulatory Technical Support
- Monitoring including QAQC
- Attention to detail
- Willingness to travel to other research sites 20% of the time

**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.