Study Coordinator

2 weeks ago

Johannesburg, South Africa AJ Personnel Full time

**The main purpose of the job**:

- To administer, maintain and coordinate the logístical aspect of clinical trials 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**:

- Helen Joseph Hospital, Johannesburg

**Key performance areas**:

- Assist in the Recruitment, Screening, and Enrolment of eligible participants according to Protocol requirements.
- Assisting in the recruitment and consenting and enrolment of study participants
- Assist the Medical Officers/Principal Investigator, and Study team in the day-to-day running of the study
- Manage scheduled and unscheduled patient visits and appointments in accordance with the study protocol
- Conduct protocol and SOP training for staff
- Liaise with the CHRU regulatory department for the reporting of SAEs and protocol deviations etc.
- Liaise with the Sponsor, Laboratory, Pharmacy, and external monitoring contractor
- 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.
- Administering trial medications and diagnostic tests if required
- Completion of Source Documentation and e-CRF’s within strict timelines
- Complete relevant research questionnaires, assessments, CRF transcription.
- Review of participant files for completeness
- Maintain and update the Investigator Site File
- Site supervision and management
- Management of freezers/fridges for samples kept at the site

**Required minimum education and training**:

- Qualified as a **Professional Nurse**

**Professional body registration**:

- Registered with the **South African Nursing Council (SANC)**

**Required minimum work experience**:

- 3 years of experience in a clinical research environment

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

- Ability to lead and work independently as well as be part of a multidisciplinary team
- Flexibility to adapt to changes in study requirements
- Ability to speak local languages
- Computer Literacy
- GCP Certification is advantageous
- Staff supervisory and management experience
- Able to exercise discretion and independent decision making
- Empathy and Understanding
- Driver’s License and own vehicle

**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 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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