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Study Coordinator

3 weeks ago

Johannesburg, South Africa AJ Personnel Full time

**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 - Chris Hani Baragwanath Academic Hospital

**Key performance areas**:
**_ Oversight of clinical trials:_**
- Assist clinical trials manager with oversight of clinical trials in conjunction with investigators and study coordinators
- Provide comprehensive support of all operational aspects of clinical 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.

**_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 clinic 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, and other
stakeholders

**_Clinic operations/management:_**
- Review status of monitors’ reports of applicable projects with Project Teams and address issues
appropriate. Provide leadership to junior study coordinators.
- Create and maintain channels of regular communication with the respective study PIs / Managers/ Study Co-Ordinator's 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.
- Delegate decision making authority, tasks, and responsibility to appropriate persons in order to maximize organisation and employee effectiveness.
- 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
- Assist 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

**_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 for driving own career development by participating in ongoing training and
development activities such as workshops, forums, conferences, etc. m. Participate and give input in ad hoc projects and initiatives.
- Mentor junior study coordinators in order to ensure high standard of quality is maintained

**Required minimum education and training**:

- **3-year Diploma or Degree in a Health-Related Field.**

**Professional Body registration**:

- **As applicable**

**Required minimum work experience**:

- **Minimum 5 years’ experience in 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 attention to detail.
- Ordered and systematic in approach to tasks, with strict compliance to protocols.
- Exceptional organisational and administrative skills with working knowledge of Microsoft Office.
- Able to exercise discretion and independent decision-making.
- Able to prioritise 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 patients’ needs and requirements.
- Ability to multi-task

**TO APPLY**:

- 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 full