Study Coordinator

**Main purpose of the job**:

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

**Location**:

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

**Key performance areas**:

- Coordinating study-specific scheduled visits, patient recruitment, and pre-screening _
- Oversee study-specific patient recruitment, pre-screening, screening, enrolment, and scheduled visits of eligible patients according to protocol requirements
- Oversee missed and pending visits and arrange home visits when applicable
- Identify obstacles in the screening and pre-screening process
- Oversee the general conduct of the trial visit procedures according to the study protocol and identify areas of concern
- Conduct study-specific training as required
- Oversee adequate study-specific files
- and record maintenance
- 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
- Report any adverse events within the required time frames
- Interact with study participants as required in terms of compliance and protocol adherence
- 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
- Trial-specific quality assurance, regulatory and data oversight _
- Ensure all study activities are conducted according to a high standard of quality
- Oversee resolution of any CRF, QC, and data queries
- Oversee adequate file preparation for monitoring visits in collaboration with the QA team
- Collaborate with CRAs as and when required
- Oversee timeous query resolution in collaboration with data and operational teams
- Oversee adequate maintenance of clinical trial logs and visit statistics
- Keeping meeting minutes for internal fortnightly clinic trials meetings
- Assist with submission of all new staff to WHREC and CRO, in collaboration with the ethics and regulatory team, and follow up on approvals and appropriate subsequent training and delegation
- Assist with collating and submission of SAHPRA/WHREC safety and progress reports and other relevant correspondence
- Assist with Investigator Site File overview and maintenance
- Assist with study-specific audit preparation
- Staff Supervision _
- Ensure that necessary performance management of all employees (relevant RA’s and CTA’s) are done timeously. i.e., Probationary appraisals, one-to-ones, performance reviews, etc.
- Attend to all staffing requirements and administration i.e. time sheets, leave forms, etc.
- Supervise and manage the duties of subordinates daily by being involved on the floor
- Identifying staff training needs and being involved with addressing these needs under senior supervision
- Assist the team with ad hoc assignments and duties
- Stakeholder Relationships _
- Actively participate in required monthly (or as needed) sponsor meetings, monitor visits, as well as weekly feedback on the project status
- Participant interaction, daily e-diary compliance as required, and follow-up on reports. Outcomes are to be communicated to the study monitor
- Participate in all phases/components of the research process from initiation to closure (Investigators' meetings, site initiation visits, etc.)
- 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

**Required minimum education and training**:

- **3-year Degree or Diploma in Nursing or Health Sciences**

**Required minimum work experience**:

- **Minimum 2 years experience in clinical trials environment**

**Professional Body registration**:

- South African National Council (as applicable)

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

- Certification in good clinical practice (GCP)
- Working experience in a medical research environment
- Thorough with good attention to detail. systematic, with strict compliance with 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-