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**:

- Show proficiency in terms of liaising with Trial Coordinating Teams, Ethics Committees, and Regulatory bodies, and timely reminders to update ethics and regulatory documentation to the aforementioned groups
- Be skilled in the evaluation of sick children, and amenable to participating in after-hours (weekend or public holiday) call-ins for in-hospital assessment of children enrolled in the Trial
- Maintain Trial logs (including participant enrolment logs, screening logs, specimen tracking, and regulatory logs) and the Investigator Site File
- Track trial participants in-hospital as well as post-hospital discharge to ensure that all trial participants attend the 4-week face-to-face clinical visit. Maintain logs to remind study staff of the dates of follow-up of trial participants
- Maintain Protocol Deviation and Severe Adverse Event/Notable Event logs, and liaise with the Study Sponsors regarding these events
- Attend to data quality queries sent out by the Trial Sponsors
- Maintain close collaboration with the Trial Monitor to ensure that the Trial runs according to Good Clinical Practice standards
- Maintain close interaction with the Laboratory Technical staff at Wits VIDA and with laboratories overseas, to ensure that Trial specimens reach laboratories on time, are stored appropriately, and are shipped to overseas laboratories
- Maintain close communication with the Trial Pharmacist Team at VIDA, to ensure that the study investigational product is available and that the expiry dates of the study investigational product are not exceeded
- Maintain open and frequent communication with the site's Principal Investigator
- Be a good Team player, with the ability to coordinate research assistants and enrolled nurses participating in the Trial

**Required minimum education and training**:

- **Enrolled/Professional Nurse with 5 years of Research experience or related managerial role**

**Required minimum work experience**:

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

**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
- 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 patients' needs and requirements
- Ability to multi-task

**Overview of the PediCAP Trial**:

- The PediCAP Trial is a multi-site trial currently underway in five sub-Saharan African countries
- It is designed to explore the efficacy of oral step-down antibiotic therapy, compared to 5 days of intravenous antibiotic therapy, in the management of severe community-acquired pneumonia in children aged 2 to 72 months
- The Wits site transitioned from PediCAP-A to PediCAP-B in mid-June 2023
- All children in PediCAP-B are randomized to oral step-down using either co-amoxiclav 4:1 or co-amoxiclav 14:1 after receiving at least 24 hours of intravenous antibiotics
- The duration of antibiotic therapy for all children in PediCAP-B is 6 days in total
- All children enrolled in PediCAP-B undergo a pharmacokinetic study blood collection, to evaluate serum levels of amoxicillin and clavulanate, after oral step-down to the Trial drug
- The last participant enrolment is estimated to be in mid-2024, and study co-ordinator input into the Trial is estimated to cease in mid
- or end-2025

**TO APPLY**:

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

**Please note**:

- **AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits He