Regulatory and Compliance Officer

2 months ago

Soweto, 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

**Location**:

- **Wits VIDA - Chris Hani Baragwanath Academic Hospital - Soweto, Johannesburg**

**Key performance areas**:

- Regulatory management_
- Create, establish, and maintain regulatory systems for all studies per regulatory authorities’ requirements
- Monitor regular and annual submission cycles and ensure updated submissions and recertifications; track and report on all regulatory department functions
- Provide guidance on the requirements of local and international regulatory bodies and frameworks, and support all relevant departments and study teams to comply with those requirements
- Review systems and recommend improvements to streamline the creation and maintenance of trial documentation
- Oversee regulatory submissions to IRBs, SAHPRA, other required bodies, and sponsors, or Clinical
- Coordinate regulatory and compliance administration and filing
- Review and ensure all regulatory essential documentation are present, maintained, and updated for studies
- Maintain Investigator site files (ISF and electronic ISF) and trial master files (in the case of sponsored studies), research staff files, and all required study essential documents according to the site or sponsor Table of Contents, SOPs, SA GCP, and ICH
- Compile relevant progress reports as well as unit-wide project management of regulatory submissions and maintenance
- Provide safety updates and reporting as required to applicable bodies
- Support unit research teams to update, maintain and control all Informed Consent forms and versions
- Develop, maintain, and implement Regulatory SOP and maintain records and updates on all unit SOPs
- Oversee capture and update all relevant study information on relevant websites/registries
- Advise and assist with Investigator Driven/Grant Funded protocols and submissions as required
- Contribute to budgeting requirements for the regulatory department
- Provide feedback and tracking of departmental expenditure in liaison with finance
- Liaise with sponsors, CROs, and applicable partners regarding regulatory matters
- Quality Control/Quality Assurance_
- Review and improve systems to monitor compliance with GCP, ensure standardization of quality control and quality assurances systems, and recommend interventions to identify, evaluate, and rectify problems
- Review and advise on improvements and standardization of quality control and assurance systems with respect to improved compliance with regulatory frameworks
- Collaborate with QC and administration teams to conduct internal monitoring regulatory file reviews regularly/every quarter and conduct participant file reviews per the Clinical Quality Management Plan (CQMP)
- Actively participate and ensure the site is well prepared for internal and external regulatory, laboratory, pharmacy, clinical, community, etc. site monitoring visits/audits/inspections, sponsor visits, site activations, etc. through preparation, follow-up, and close-out of findings - this includes quality assurance pre-checks
- Assist sponsors/monitors before, during, and after reviews
- Contribute to and maintain Clinical and Laboratory Quality Management Plans in conjunction with clinic and laboratory management
- Contribute to unit Quality Assurance and Quality Control management (establish a committee)
- Prepare quality management reports in liaison with lab, clinic, and applicable study quality teams
- Respond to monitoring and quality queries as required
- Staff management_
- Attend to all staffing requirements and administration
- Supervise and manage the duties of permanent and fixed-term or ad hoc team members to ensure optimal staff
- Perform and facilitate performance development and assessments
- Identify substandard performance by team members and take necessary corrective action
- Coach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organization
- Promote harmony, teamwork, and sharing of information
- Effective self-management, and performance ownership_
- 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 research environment with demonstrable regulatory coordination experience**

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

- Understanding of the resear

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