Study Coordinator

**Main purpose of the job**:

- To administer, maintain and coordinate the logístical aspects of clinical trials according to good clinical practice, the study protocol, and the standard operating procedures and to act as a pivotal point of contact for the clinical trial team and the donors

**Location**:

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

**Key performance areas**:

- Staff Supervision and training_
- Performance management of all employees (relevant RA’s and CTA’s) are done timeously. i.e., Probationary appraisals, Monthly meetings, performance reviews, etc.
- Attend to all staffing requirements and administration i.e., timesheets, HR Online, etc.
- Supervise and manage the duties of subordinates daily
- Assist the team with ad hoc assignments and duties in line with protocol requirements
- Create and maintain channels of regular communication with the PIs/Managers/Study Coordinators and Ethics & Regulatory team to ensure work of high quality is delivered, in line with protocol requirements
- Work as a team to enforce standard policies, procedures, and Standard Operating Procedures of VIDA
- Identify quality improvement initiatives and staff training needs and provide resolutions
- Delegate tasks accordingly to ensure optimal efficiency
- Mentor junior study coordinators in order to ensure a high standard of quality is maintained
- 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
- Interact with participants daily to ensure daily e-diary compliance as required and follow up on reports
- Review the status of monitors' reports of applicable projects with Project Teams and address issues appropriately
- Clinical Operations_
- Oversee trial-specific patient recruitment, pre-screening, screening, and enrolment of eligible patients according to protocol requirements
- Assist and mentor junior study coordinators to ensure adequate study enrolment and retention is maintained
- Pro-actively identify and troubleshoot obstacles in the screening and pre-screening process, assist clinical trials manager in the resolution thereof
- Conduct study-specific training as required
- Oversee adequate trial-specific files
- and record maintenance
- Oversee trial-specific visit booking schedules
- Oversee active follow-up on missed and pending visits and arrange home visits as applicable
- Oversee maintenance of adequate study-specific records including paper logs and electronic logs
- Oversee management and printing of up-to-date versions of study source documents
- Oversee general conduct of the trial according to the study protocol, and pro-actively troubleshoot and identify areas of concern
- Report any adverse events within the required time frames
- Perform relevant study administration i.e., checking laboratory invoices weekly
- Oversee relevant trial stock management and ensure adequate stock levels are always maintained, and expired stock is sent for destruction timeously
- Create and maintain channels of regular communication with the respective study PIs/Managers/Study Coordinators and the Executive Director
- 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
- Manage the essential documents, as required by local regulations and ICH GCP, before, during, and after a clinical trial like training logs, delegation logs, enrolment, and screening logs
- 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 the Health-Sciences field**

**Required minimum work experience**:

- **Minimum 5 years experience in a clinical trials environment, or 6-12 months experience as a junior study coordinator**

**Professional Body registration**:

- South African National Council if applicable

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

- Demonstrable experience with training, quality assurance, regulatory affairs, trial management, and CRO liaison
- Thorough with good attention to detail
- Or