Study Coordinator

7 days ago

Klerksdorp, South Africa AJ Personnel Full time

**Main purpose of the job**:

- To administer, maintain and coordinate the logístical aspect of the Fedisa TB study according to Good Clinical Practice, study Protocol, and Standard Operating Procedures and act as a pivotal point of contact for the clinical trial team and the sponsor

**Location**:

- **PHRU - Tshepong Hospital, Matlosana, Klerksdorp**

**Key performance areas**:

- Assist in the recruitment, Screening, and Enrolment of eligible clinics and participants according to Protocol requirements
- Review data as set out by the study protocol
- Assist the Principal Investigator and Study team in the day-to-day running of the study
- Manage scheduled and unscheduled patient visits and appointments where required in accordance with the study protocol
- Conduct protocol, SSP, and SOP training for staff
- Liaise with the PHRU regulatory department for the reporting if SAEs and protocol deviations etc.
- Liaise with the Sponsor, Laboratory, Pharmacy, and external monitoring contractor
- Liaise with clinic staff and research team for efficient data collection
- Perform participant’s vitals (as and when required) and direct patients to relevant assessment.
- Assist with study specimen collection (i.e. blood, urine, sputum, cervical specimens, and semen)
- Collect - process and ship specimens as per protocol where required
- Administering trial diagnostic tests if required
- Completion of Source Documentation
- Complete relevant research questionnaires, assessments, CRF transcription
- Review of participant files for completeness
- Maintain and update the Investigator Site File
- Maintain a good system for reporting daily study activities
- Site supervision and management
- Compiling and submission of study progress reports
- Coordinate study update meetings

**Required minimum education and training**:

- **Qualified as Professional Nurse**:

- **Registered with the South African Nursing Council**

**Required minimum work experience**:

- **2 years experience in a clinical research environment**

**Professional body registration**:

- **Registered with the South African Nursing Council**

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

- Computer literacy - competence in MS Word and Excel essential
- Staff supervisory and management experience
- The ability to speak local languages
- Able to exercise discretion and independent decision making
- Empathy and understanding for people living with HIV/AIDS
- Ability to work under pressure

**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.

**Please note**:

- **Our Client, WHC - PHRU, maintains mandatory Covid-19 requirements, and as such only Covid-19 vaccinated incumbents will be considered for positions.**:

- WHC, in accordance with its 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.
- AJ Personnel is only responsible for advertising the advertisement on behalf of their client Wits Health Consortium.
- AJ Personnel does not have any salary or other information regarding the position.

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