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Study Coordinator

4 months ago

Johannesburg, South Africa AJ Personnel Full time

**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**:

- **CHRU, Wellness Clinic, Sizwe Tropical Disease Hospital, Johannesburg**

**Key performance areas**:

- Assist in 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 the relevant assessment
- 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-CRFs within strict timelines
- Complete relevant research questionnaires, assessments, CRF transcription
- Review of participant files for completeness
- Maintain and update the Investigator Site File
- Management of freezers/fridges for samples kept at the site

**Required minimum education and training**:

- **Qualified as an Enrolled Nurse or Professional Nurse**

**Required minimum work experience**:

- **3 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**:

- Phlebotomy skills, especially in paediatrics, are advantageous
- Experience with pharmacokinetics trials
- Ability to 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
- Able to exercise discretion, independent decision making and problem-solving
- Empathy and Understanding
- Driver’s License and own vehicle
- Experience in the conduct of DAIDS (IMPAACT/ACTG/etc) trials is desirable

**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 Health Consortium.**:

- **AJ Personnel does not have any salary or other information regarding the position.