Regulatory and Compliance Officer

2 weeks 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**:

- Oversight of clinical and investigator-led trials _
- Assist research administration manager with oversight of all trials in conjunction with investigators and study coordinators
- Provide comprehensive support of all operational aspects of trials including overall delivery of protocol objectives, logistics, visit scheduling including home visits, administration, reporting, and data collection
- Ensure research teams maintain protocol integrity and participant safety throughout the study
- Participate in or support investigators as needed in generating source documents, designing and review of protocol-specific forms and study-related documents
- Lead or coordinate staff training interventions related to protocols as required
- Liaison with other departments as required to ensure study deliverables are met and processes effectively
- Knowledge of local clinics and Department of Health SOPs and guidelines essential
- Stakeholder relationships and customer service _
- Actively participate in required monthly (or as needed) sponsor meetings, monitor visits, as well as weekly feedback on the project status
- Participate in all phases/components of the research process from initiation to closure (Investigators' meetings, site initiation visits, etc.)
- Support a research environment and culture that is mission-focused and aligned with our core values
- Build and maintain authentic relationships with all stakeholders ensuring that all interactions are professional
- Establish and maintain a relationship of trust and respect with participants, sponsors, CROs, hospital and clinic partners, and other stakeholders
- Regulatory and compliance management _
- Review the status of monitors’ reports of applicable projects with Project Teams and address issues appropriately
- Provide leadership to junior study coordinators and regulatory team
- Create and maintain channels of regular communication with the respective study PIs/ Managers/Study Co-ordinators and research leadership
- Enforce standard policies and procedures of VIDA in all operations as well as Ethical guidelines and principles of Good Clinical Practice and ensure compliance
- Identify quality improvement areas in each project and ensure appropriate strategy and quality improvement initiatives are developed and measured
- Delegate decision-making authority, tasks, and responsibility to appropriate persons to maximize organization and employee effectiveness
- Manage the essential documents as required by local regulations and ICH GCP before, during, and after a trial like training logs, delegation logs, enrolment
- and screening logs
- Assist research administration and clinical trials manager with resource planning and management
- Assist clinical trials operations manager with oversight of departmental administration including adequate maintenance and availability of all supplies and equipment
- Keep track of GCP bookings, maintain the tracker, and report on expenditure
- Effective self-management, and performance ownership _
- Take ownership and accountability for tasks and demonstrate 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 workshops, forums, conferences, etc.
- Participate and give input in ad hoc projects and initiatives
- Mentor junior study coordinators to ensure a high standard of quality is maintained

**Required minimum education and training**:

- **3-year Diploma or Degree in a health-related field**

**Required minimum work experience**:

- **Minimum 5 years experience in a clinical trials environment**

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

- Demonstrable experience with training, quality assurance, regulatory affairs, trial management, and CRO liaison
- Thorough with good diligence
- Ordered and systematic in approach to tasks, with strict compliance to protocols
- Exceptional organizational and administrative skills with working knowledge of Microsoft Office
- Able to exercise discretion and independent decision-making
- Able to prioritize own workload, take initiative (pro-active) and work to tight deadlines
- Self-motivated with high regard for work ethic, values, and integrity
- Display concern for patients and willingness to respond to patient's needs and requirements
- Ability to multi-task

**TO APPLY**:

- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated C

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