- To monitor and ensure compliance with regulatory and good clinical research practice requirements within research studies
- Wits VIDA - Chris Hani Baragwanath Academic Hospital Soweto, Johannesburg
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
- 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
- Ensure all customer interaction (both internal and external customers) is of the highest professional level, e.g., respond to emails/queries within a reasonable period
- 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
- 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
- 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
- 3-year Diploma or Degree in a health-related field
- Minimum 5 years experience in a clinical trials environment
- 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
- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- Please Apply Online.
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- The closing date for all applications: 20 February 2023.
- 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.
- AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
- Wits Health Consortium will only respond to shortlisted candidates.
- Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful.
- AJ Personnel does not have any salary or other information regarding the position.
- Communication
- Computer Skills
- Computing
- Healthcare
- Medical
BackgroundThe Vaccines and Infectious Diseases Analytics (VIDA) Research Unit of the University of the Witwatersrand, formerly RMPRU (Respiratory and Meningeal Pathogens Research Unit) has for over 20 years conducted numerous studies to assess the burden of and prevent vaccine-preventable diseases (VPD).Current studies and projects include infant rotavirus and BCG trials.
Employer & Job Benefits
- Medical Aid Contribution
- Provident Fund Contribution
