Study Coordinator

**Main purpose of the job**:

- To administer, maintain, capture, and coordinate the logístical and clinical aspects of COVID-19 and non-pandemic clinical trials run by the JHB Pulmonology Syndicate according to Good Clinical Practice (GCP), the study protocol, and the standard operating procedures

**Location**:

- **Charlotte Maxeke Johannesburg Academic Hospital and Bertha Gxowa Hospital (Germiston)
***Key performance areas**:

- Manage scheduled and unscheduled patient visits and appointments in accordance with the study protocol
- Study patient contact activities and files prior to screening visits
- Perform patient vitals (i.e., blood testing) and basic bedside investigations if required
- Report any adverse events to the Principal and Sub-investigators
- Maintain accurate and complete files and documentation, including but not limited to regulatory documents, signed informed consent forms, source notes, patient and screening logs, and study-related communications (i.e CRFs, Quality of Life Assessment)
- Perform data capturing (ECRF)
- Assist in patient recruitment, screening, and enrolment of eligible patients according to protocol requirements
- Book and/or perform study-specific pre-screening or screening and provide background information to patients prior to the informed consent process
- Quality control patient files and data entries i.e ECRF’s, CRF’s
- Proactively resolve protocol queries and missing data with Medical Officers and Clinical Trials Assistants.
- Follow up and control SAE
- Prepare files for monitoring requirements and meet with CRAs as and when required
- Attend Investigator and Site Initiation meetings prior to commencement of the clinical trial
- Assist the Pharmacist with IVRS acknowledgment of drug shipments and ensure that the original Pharmacy script is returned
- Provide clinical trial and CRF training to Clinical Trail Assistants

**Required minimum education and training**:

- **Nursing Diploma (or equivalent)**:

- **Certification in project management and good clinical practice (GCP) will be an advantage**

**Required minimum work experience**:

- **Minimum 2 years experience in a clinical trial environment**

**Professional Body Registration**:

- Registration with SANC or HPCSA

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

- Thorough with good attention to detail
- Ordered and systematic in approach to tasks, with strict compliance to protocols Exceptional organizational and administrative skills are required together with working knowledge of MS suite and the use of electronic tablets for data gathering and management
- Ability to exercise discretion and independent decision-making.
- Travel between the two hospitals and working in clinical environments involving general ward and ICU areas with patients with COVID-19 will be necessary

**TO APPLY**:

- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- _AJ Personnel is fully POPIA Compliant._
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- 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 Health Consortium.
- AJ Personnel does not have any salary or other information regarding the position.